1. This study will compare the efficacy of single session of ketamine-assisted psychotherapy of heroin addiction with multiple (three) sessions regime. We seek to determine whether the repeated sessions of ketamine psychotherapy (KPT) carried out with one month interval will improve the efficacy of single KPT session treatment of heroin addiction as reflected in objective measures of treatment outcome. This outcome would be demonstrated by a statistically greater and/or more sustained clinical and psychological improvements in heroin addicts taking three sessions KPT.

2. To study the effect of every repeated KPT session on clinical and psychological symptoms of heroin addiction (such as craving for heroin, anhedonia, anxiety, depression and purposes in life). We seek to determine which kinds of clinical and psychological transformations will be induced by second and third KPT sessions in comparison to changes induced by first session and how all above changes related to the treatment outcome (rate of abstinence).

Many studies suggested that hallucinogen-assisted (psychedelic) psychotherapy might be an efficient treatment for the addiction in the 1950's and 1960's (Grinspoon and Bakalar, 1979), but different methodologies made it difficult to generalize across studies. The requisite development of appropriate sophistication of these studies was not possible after psychedelics were scheduled in 1970 and their use was strictly limited. However, data collected in 1950's and 1960's provide some important insights about treatment effects of psychedelic psychotherapy that had been summarized in Halpern's (1996) comprehensive review. The further parts of this section are quotations form the Halpern's 1996 review.

"Abuzzahab and Anderson's 1971 review of 31 investigations from 1953 to 1969 on the effects of LSD on 1105 alcoholics (variably defined, with a mean length of alcoholism of 19.4 years) did reach some interesting conclusions. There are five studies noted in which a single LSD dose (mean 342 mg) was given to alcoholics and control groups (Jensen, 1962; Jensen and Ramsey, 1963; Johnson, 1969; Ludwig et al., 1969; Smart et al., 1966). Combined improvement in alcoholics is reported as 75% versus 43.7% of controls on a mean follow-up of about 10 months. As for the three studies in which multiple doses of LSD were given (MacLean et al., 1967; Osmond et al., 1967; Van Dusen et al., 1967) improvement was 57.5% for patients and 70.5% for controls after a mean follow-up of 20 months. The mean dose, unfortunately, could not be determined because MacLean et al. (1967) did not report the maximum total dose. Still it should be noted that the average follow-up in these three studies is twice as long as in the former five single-dose studies mentioned.

Again, differences in definitions of improvement and length of follow-up, make one suspicious of all these data. Moreover, none of the studies report if there are changes in psy-chosocial adjustment following LSD treatment. Still, the reviewers (Abuzzahab and Anderson, 1971) emphasize that "discrepancies in improvement might be related to longer follow-up; [for] the longer the follow-up, the less the improvement" was noted across the single dose studies. Indeed, this has been alluded to by others (Faillace et al., 1970; Mottin, 1973; Shaggas and Bittle, 1967; Soskin, 1973; Ulrich and Patten, 1991). Such a contention supports the hypothesis that lysergamide (ex. LSD), indolealkylamine (ex. DMT, ibogaine, psilocybin), and/or phenethylamine (ex. mescaline, MDMA) hallucinogens offer anti-addictive properties that last an undetermined but finite average length or time. Thus, through repeated dosing at such intervals as deemed necessary, the addict could receive a continuous (steady-state) benefit. If true, then we should find a diminution of the addict's substance use with a quantifiable improvement in global adjustment and level of functioning. Indeed, Grinspoon and Bakalar's exhaustive review (1979) arrived at a similar conclusion: "Some controlled studies show an improvement lasting from several weeks to several months. The obvious recourse of supplementary treatments every once in a while has been suggested but never taken seriously possibly because everyone is mesmerized by the vision of a quasi-miraculous single-shot cueŠ When it becomes possible to continue therapeutic research with psychedelic drugs, an experiment along this line might be considered, not only for alcoholics, but for other patients. Does the afterglow diminish after few psychedelic trips, or can it be renewed periodically to some useful effect? Can the patient take advantage of the temporary reduction in anxiety and depression to change habits and achieve further insights? ... By renewing the psychedelic experience every few weeks or months, the peyote ritual provides the kind of continuous follow-up implicitly suggested by the studies that indicate a short-term improvement after an LSD trip."

Smart et al.(1967) also admit that there has been "little consideration of the role of multiple doses of LSD in the treatment of alcoholism....It is possible that a long series of administrations would have provoked more change."

When one weighs this literature, including the few double-blind, controlled studies, it can be seen that there could be anti-addictive benefits lasting one or two months. One of the better designed studies (Hollister et al., 1969) had subjects (N = 72) randomly assigned to two groups in which one was given a single dose of 600 mg of LSD and the other 60 mg of dextroamphetamine. No psychotherapy was provided to either group, and LSD or amphetamine was administered double-blind. Both groups were independently rated for level of alcoholism on two and six month follow-up. At two months the investigators report a statistically significant (p < 0.01) improvement with the LSD treated group over the amphetamine group when comparing scores on a "Drinking Behavior Scale." This scale, formulated by the authors, is intended to be "based on the three general areas of drinking habits, social behavior, and occupational adjustment." At six months the two groups showed no difference. It is quite possible, then, that this hallucinogen had up to a two-month anti-addictive property with these alcoholics. If true, this would also explain why the single-dose LSD experiment of Smart et al. (1967) found no improvement in alcohol consumption in their well-designed, double-blind, placebo and drug controlled experiment (N = 30): follow-up of all subjects occurred at six and 18 months.

In another well regarded paper, Ludwig et al. (1969) conducted a three-year study of 176 male alcoholics. The subjects were randomly assigned to four different treatment modalities operated under double-blind conditions. Their analysis of the study: "Although the results indicated significant improvement from baseline to post-treatment and follow-up testing for all treatment conditions (including the no-therapy condition), no one treatment condition proved superior to any other. Therefore, we were forced to conclude that the dramatic claims made for the efficacy of LSD treatment in alcoholism were scientifically unjustified." However, their own figure on the cumulative percentage of patients who returned to drinking shows a discrepancy in their conclusion (Kantor, 1970). Namely, at one month follow-I up fewer than 15% of those who had "psychedelic" therapy returned to drinking as opposed to 40% of the control group. Strangely, the authors maintain that this should not be construed as a "positive sign" (Ludwig, 1970).

Human trials to study anti-addictive effects of hallucinogens on opioid dependency are sparse. Ludwig and Levine (1965) evaluated narcotic addicts (N = 70) after the completion of a detoxification program. Volunteers were randomly assigned to five different treatment sessions: "insight-interpretive" psychotherapy alone, hypnosis plus psychotherapy, LSD alone, LSD plus psychotherapy, and LSD with hypnosis and psychotherapy ("hypnodelic therapy"). A moderate dosage of 2 mg/kg of LSD was administered to those in the latter three groups. The authors report that on psychological testing, those who received LSD showed significant improvement at two weeks on scales testing for "Self-concept" and "Coping Attitudes" in comparison to those who did not. No differences were noted at two months, although the authors believe that the greatest improvements were seen in the hypnodelic group. This study actually provides quite limited conclusions since behavioral changes, including abstinence from drugs, were not tracked.

Savage and McCabe (1973) did, however, track 74 narcotic addicts for one year with daily urine monitoring for continued abstinence. Subjects randomly assigned to the study group stayed for six weeks in a half-way house and were given several weeks of preparatory psychotherapy prior to being given a single moderate to high dose of LSD (200 to 500 mg). Controls were placed in an outpatient clinic program with weekly group psychotherapy. Other than the initial period of residential treatment culminating in LSD administration, study subjects and controls were treated identically. Their results after one year: 25% of the study group remained abstinent from opiates as opposed to only 5% of the control group (p < 0.05). The authors cautiously note that LSD was only one component of the six week initial therapy and as such "one is not able to say that it was the drug factors alone which accounted for the therapeutic yield." Indeed, the residential treatment given to the study group may have skewed these results. Still, it would appear that LSD had a distinct effect on outcome. They encouraged further research with hallucinogens in the treatment of narcotic addicts, but by 1973, when their study was published, human research with these controversial substances had essentially come to an end in America.

"For reasons not sufficiently understood, alcoholics and drug addicts seem to respond better to large-dose psychedelic therapy than do the other diagnostic categories, which require repeated drug administrations with the systematic working through of problems" (Grof, 1970). Pahnke et al. (1970) describe this positive post-hallucinogen experience as an afterglow occurring in subjects after they have a transcendent "psychedelic" event from relatively high dosing: "If a psychedelic-peak experience has been achieved and stabilized during the session, a clinical picture which we have termed the psychedelic afterglow can be observed in the days after the session. Mood is elevated and energetic; there is a relative freedom from concerns of the past and from guilt and anxiety, and the disposition and capacity to enter into close interpersonal relationships is enhanced. These psychedelic feelings generally persist for from two weeks to a month and then gradually fade into vivid memories that hopefully will still influence attitude and behavior. During this immediate postdrug period, there is a unique opportunity for effective psychotherapeutic work on strained family or other interpersonal relationships."

Interestingly, Albaugh and Anderson (1974) attest to observing such an afterglow lasting seven to 10 days in Native American alcoholics who partake in the peyote meetings of the Native American Church. Others have also noted the anti-addictive potency of participation in this religion's peyote ceremonies (La Barre, 1970; Roy et al., 1970; Roy, 1973).

Savage and McCabe (1973) noted in their study that of the 13 narcotic addicts who had perfect community adjustment scores after one year, 12 had psychedelic-peak responses to LSD. Furthermore, Pahnke et al. (1970) and Kurland et al. (1971) investigated whether improvement occurred to a greater degree in those alcoholic patients who reported a "psychedelic-peak" experience through high dose therapy. An actual randomly assigned, double-blind protocol with controls was conducted (N = 117). Subjects in the experimental group received a single 350 mg to 450 mg dose of LSD as opposed to only 50 mg administered to controls. Independent evaluators observed a statistically significant (p < 0.05) improvement in global adjustment and drinking behavior on six-month follow-up when comparing these two groups: 53% of the high-dosage group were "greatly improved" as opposed to only 33% of the low-dosage group. After 18 months no differences were found between these two groups. Once again we find a significant anti-addictive benefit lasting several months.

Pahnke and colleagues laid the groundwork for showing wherein may lie the therapeutic potential of the hallucinogens in the treatment of addictions. Namely, could it be the "afterglow" that is the source of therapeutic benefit? What would occur if a series of treatments were spaced to provide a sustained "afterglow"? Would the patient have the motivation to deal more effectively with his addiction?" (Halpern, 1996). If hallucinogen-assisted psychotherapy helps to moderate the "sense of craving, the addict could be provided with the additional independent tool to help regain some measure of control and perhaps achieve abstinence. With continued abstinence, craving hopefully diminishes to a manageable level." (Halpern, 1996).

Our previous double blind controlled randomized clinical trial showed that ketamine-assisted psychotherapy of heroin addiction with psychedelic dose of ketamine (2.5 mg/kg i.m.) is more effective than KPT with low non-hallucinogenic dose of ketamine (0.25 mg/kg) (Krupitsky et al., 2000). In that study we carried out only one KPT session for all heroin addicts. But the important question still to be answered is: Can the efficacy of KPT of heroin addiction be increased by doing multiple KPT sessions and thus stabilizing the afterglow? This protocol is designed to answer that question.

1. Design:

Eighty heroin addicts will be assigned to one of two groups on the randomly selection basis. The randomization will be done after the first KPT session (in a week or so before the second session either KPT or counseling).

The subjects of the experimental group will receive three KPT sessions against the background of hallucinogenic (psychedelic) dose of ketamine (2.0 mg/kg i.m.) with one month interval between the sessions. They will receive their first KPT session as in-patients after detoxification and right before they discharged from psychiatric hospital. They will come to the same hospital in one and two months for the second and third KPT sessions as out-patients. They will have an individual counseling session every time before repeated (2nd and 3rd ) KPT session. The subjects of the control group will receive only one KPT session wit the same dose of ketamine and same psychotherapeutic technique. They will receive KPT session as in-patients after detoxification and right before they discharged from psychiatric hospital. They will come to the same hospital in one and two months only for an individual counseling session with the same psychotherapist who carried out KPT session.

All patients will be treated alike and will be given the same preparation for KPT. The KPT sessions, regardless of their number, will be given under constant circumstances. All patient's psychological and clinical evaluations during the treatment and follow-up period will be done by a clinician evaluator other than psychotherapist providing KPT who will be blind as for the number of KPT sessions.

2. Patients:
Eighty heroin addicts will be screened, evaluated and randomized in the study. Patients will be recruited from the in-patient department of St.Petersburg Regional Center of Addictions (which is a regional center for the treatment of alcoholism and drug dependency with a hospital for 300 beds) after they have completed the detoxification. Informed consent will be obtained from all patients prior to acceptance into the study. All patients will be accepted in the study as in-patients and will be discharged from the hospital after they have completed one KPT session. All subjects will be randomized into one of two treatment arms in a week before the second session.

3. Psychotherapist:
Psychotherapy will be provided by a psychotherapist (MD) who is specially trained in KPT. All KPT sessions will be done by one and the same psychotherapist.

4. Patient's selection:

The following exclusion and inclusion criteria will be employed:

a) Inclusion criteria:

• ICD-10/DSM-IV criteria of current Heroin Dependence, present for at least one year
• Age between 18 and 30
• At least high school education
• Abstinence from heroin and other substances of abuse for at least two weeks
• Not currently on psychotropic medication
• At least one relative willing to assist in follow-up and provide outcome data
• Stable address within St. Petersburg or nearest district of Leningrad Region
• Home telephone number at which the patient could be reached
• Not currently on probation
• Competency to give informed consent and otherwise participate

b) Exclusion criteria:

• ICD-10/DSM-IV criteria of organic mental disorder, schizophrenic disorder, paranoid disorder, major affective disorder, and seizure disorder
• ICD-10/DSM-IV criteria for alcoholism or polydrug dependency
• Advanced neurological, cardiovascular, renal, or hepatic diseases
• Pregnancy
• Family history of psychiatric disorders listed above
• Clinically significant cognitive impairment
• Active tuberculosis or current febrile illness
• AIDS-defining illness
• Significant laboratory abnormality such as severe anemia, unstable diabetes, or liver function tests >3X above normal
• Pending legal charges with potential impending incarceration
• Concurrent participation in another treatment study
• Concurrent treatment in another substance abuse program

5. Screening evaluation will include:

• Formal psychiatric examination
• Standard medical examination, including blood chemistry panel (including hepatic functions), urine analysis, HIV-test, pregnancy test and EKG
• Review of previous medical and psychiatric records

6. Battery of the assessment instruments:

In choosing the battery of assessment instruments, care was taken to include those instruments we already successfully used in our previous studies of KPT of heroin addiction to provide comparability with that studies.

a) Psychiatric symptoms and psychopathology:

1. ICD-10 Structuralized clinical interview for psychiatric disorders (CIDI).
2. Addiction severity index (ASI) (McLellan et al., 1985) - clinician administered instrument that elicit information about a drug abuser's problems in six areas: Drug use, medical, psychological, legal, social and occupational.
3. Zung self-rating depression scale (ZDS) (Zung, 1965) - to assess patient's depression.
4. Spielberger self-rating state-trait anxiety scale (SAS) (Spielberger et al., 1976) - to assess patient's level of state and trait anxiety.
5. Visual analog scale of craving (VASC) - 100 mm line marked by subjects in proportion to the intensity of craving experienced while completing the scale.
6. Scale of Anhedonia syndrome (SA) (Krupitsky et al., 1998) ­ this scale was developed to assess the severity of the syndrome of anhedonia. Many detoxified heroin addicts report that the termination of withdrawal leads to a syndrome of anhedonia which includes affective symptoms (mostly depression), anxiety, tension, irritation, feeling like life is dull and empty, passivity, sleep disturbance, and craving for heroin. SA has affective, cognitive, and behavioral subscales.

1. Purpose-in-Life Test (PLT) (Crumbaugh, 1968) based on the Frankl's (1978) concept of the man's aspiration for the meaning of life - to assess the patient's understanding the meaning of life.

7. Treatment assessment, outcome and follow-up:

a) Assessment schedule:

• Urine drug testing will be done before the 2nd and 3rd KPT + counseling sessions in the experimental group, and each of two counseling sessions in the control group.
• CIDI and ASI will be administered only pre-therapy (baseline).
• ZDS, SAS, VASC, SA, and PLT will be administered before and after first KPT session in both groups, 2nd and 3rd KPT + counseling sessions in the experimental group, and each of two counseling sessions in the control group as a comprehensive test battery sensitive to the changes over the course of this study.
• ZDS, SAS, VASC, SA, and PLT will be administered also in 1, 3, 6 and 12 months after the end of treatment (that is 3rd KPT + counseling session in the experimental group and last counseling session in the control group) to assess the quality of life in those patients who will be abstained from heroin.
• Also all patients will be asked to write a detail self-report about their experiences during each ketamine session. This self-report will contain evidences of presence or absence of a peak experience during the ketamine session.

• The information from the patient about his/her drug use during the follow-up period (these information will be collected using Time Line Follow Back technique).
• The information from the patient's relatives and/or colleagues about patient's drug use.
• Investigation of the presence or absence of the traces (marks) of injections on the patient's veins in 1, 3, 6 and 12 months since the end of treatment (that is 3rd KPT + counseling session in the experimental group and last counseling session in the control group).
• Urine drug testing in 1, 3, 6 and 12 months since the end of treatment (3rd KPT + counseling session in the experimental group and last counseling session in the control group).

Description of the psychotherapy:
Three main stages in our method of KPT can be distinguished (Krupitsky and Grinenko,1997). The first stage is preparation. In this stage, preliminary psychotherapy is carried out with patients. During these psychotherapeutic sessions it is explained to the patients that the relief of their dependence from heroin will be induced in a special state of consciousness in which they will have deep experiences that will help them to realize the negative effects of heroin abuse, and the positive aspects of life without drugs. We explain that the psychedelic session may induce important insights concerning their personal problems, their system of values, notions of self and the world around them, and the meaning of their lives. All of these insights may entail positive changes in their personality, which will be important for their shift to a new lifestyle without heroin. During the ketamine sessions, patients often experience the separation of consciousness from the body and the dissolving of the ego, so it is very important to prepare patients carefully for such an unusual experience. This information is not presented to the patient in the form of a didactic monologue from a psychotherapist. The abstract "psychotherapeutic myth" is not simply explained to the patient; it is discussed with him and embroidered with specific concrete content during a dialogue. The therapist pays close attention to such issues as the patient's personal motives for treatment, his goals for his new life without drugs, his idea of the cause of his disease and its consequences, and so on. An individually tailored "psychotherapeutic myth" is formed during this dialogue. It becomes the most important therapeutic factor responsible for the psychological content of the second stage of the KPT. It is also very important to create a specific atmosphere of confidence and mutual understanding between a psychotherapist and a patient during the first stage of KPT.

The second stage is ketamine session itself. With a background of special music (generally, new age composers, such as Kitaro and Jean Michel Jarre) the patient having a KPT session is exposed to psychotherapeutic influences. The content of these influences is based on the concrete data of the patient's anamnesis (case history) and is directed toward the resolution of the patient's personality problems and toward the formation of a stable orientation towards the life without drugs. We try to help our patients create a new meaning and purpose in life during this session. The specific character of our KPT method allows us to carry out a special psychotherapeutic dialogue with the patient undergoing their psychedelic experience. We emphasize the positive values and meaning of life without drugs and the negative aspects of drug abuse during this dialog, which has a specific personal orientation for each patient. It is also very important to direct carefully the patient's psychedelic experiences by the verbal influences and manipulating with a musical background towards the symbolic resolution of the personality conflicts and final cathartic peak experiences. Second stage of KPT is conducted by two physicians, a psychotherapist and an anesthesiologist, because some complications and side-effects (such as increased blood pressure, convulsions, depression of breath) are possible, though exceedingly rare. All KPT sessions will be carried out in the intensive care room of the hospital. After the session, the patient goes to rest, and we ask them to write down a detailed self-report of their experience that evening.

In the third stage, special psychotherapy is carried out the day after the KPT session. During this session the patients discuss and interpret the individual personal significance of the symbolic content of their experience with the psychotherapist. This discussion is directed toward helping the patient make a correlation between their psychedelic experience with their intra- and interpersonal problems (primarily those connected with drug abuse), and thereby to solidify their desire for a life without drugs. We try also to assist patients to integrate the insights from the psychedelic session into the everyday life. The uniquely profound and powerful psychedelic experience often helps them to generate new insights that enable them to integrate new, often unexpected meanings, values and attitudes about the self and the world.

9. Data management and statistical analysis:

Student t-test for independent samples will be employed to assess differences between the experimental and control group in the scores of clinical and psychological ratings and in the rate of abstinence.

MANOVA within subjects repeated measures of analysis design with Tukey test for post-hoc comparisons will be employed to assess the effect of repeated KPT/counseling sessions and the follow-up time. Independent variables: number of the KPT session, follow-up time point; dependent variables: ZDA, SAS, VASC, SA, and PLT scores.

10. Possible project's duration: 5 years.

In our previous study of KPT for heroin addiction (Krupitsky et al., 2000) approximately 70% of the patients were abstinent in two months after KPT session. We predict that about 10% of those patients who stay abstinent will not come for the 2nd KPT/counseling session and another 10% - for 3rd KPT/counseling session for many different reasons other than relapse. Thus, we expect that only 60 % of the subjects initially included into the study will come for two KPT/counseling sessions, and 50% - for three sessions. We will treat 10 patients in the experimental and 10 patients in control group every year. Thus, we will need 4 years to treat 80 subjects with at least with one KPT session. We will need another (fifth) year for follow-up and data analysis. We expect that 40 (20 in the experimental group and 20 in control) out of 80 patients initially included into the study will come for all three KPT/counseling sessions.

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