Purpose: Neuropsychological, psychopharmacological: "to determine an appropriate dose range for MDMA and mCPP in a population of moderate MDMA users under clinical laboratory conditions" (p. 98).
Design: Placebo-controlled, non-randomized between subjects/within-subjects design. Drug class (MDMA or mCPP) and dose (75, 110 or 145 mg/70 kg MDMA, 17.5, 35 or 52.5 mg/70 kg mCPP) served as between-subjects variables. Drug treatment (placebo or drug) and time of measurement (pre-drug to post-drug) serving as within-subject variables. Dose conditions for MDMA and mCPP were both done in ascending order, with low dose conditions completed first before assigning people to higher dose conditions. There were 6 drug class/drug dose conditions with 5 participants in each condition, but 7 / 22 participated in 2 conditions and 1 / 22 participated in 3 conditions. All participants received 1 placebo session paired with 1 drug treatment session, with vital signs, mood and alterations in consciousness measured in both sessions.
Subjects: 22 MDMA-experienced volunteers (14 women, 8 men, average age 23.6 years) presumably residing in or near Detroit, participated in this study. 20 / 22 were white, 1 was bi-racial and one Arabic.
Criteria for Inclusion - Healthy, with absence of past or current major medical or psychiatric illnesses, absence of diagnosed alcohol or drug dependence, being between the ages of 18 and 40, and having obtained at least a high school education. History of moderate ecstasy use, defined as having used stimulants at least 6 times and having used ecstasy at least 3 times; no maximum number of uses stated, but ecstasy use ranged from 3-40 tablets in a lifetime. Measures: Physiological Effects - BP (systolic and diastolic), and HR were measured hourly immediately after drug or placebo and 1, 2, 3, 4, 5 and 6 h post-drug.
Mood - Mood was measured by Profile of Mood States (POMS), and by visual analog scales (VAS) for 6 mood states (stimulated, high, anxious, sedated, down, hungry) and drug liking. Both measures were administered hourly immediately after administration, 1, 2, 3, 4, 5 and 6 h post-drug.
Alterations in Consciousness - Alterations in consciousness were measured via short version of ARCI and the Hallucinogen Rating Scale (HRS). Both measures were administered hourly 1, 2, 3, 4, 5 and 6 h post-drug. The ARCI was administered immediately after drug, but the HRS was first administered 1 h post-drug.
Drug Identification - Measured by an end-of-session questionnaire completed 6 h post-drug. Participants were asked to identify the drug they received (stimulant, empathogen (MDMA-like drug), hallucinogen, sedative or placebo).
Analyses: Physiological Effects - A repeated measures analysis was performed on systolic BP, diastolic BP and HR, with drug treatment (placebo versus drug) serving as one within-subjects factor and time of measurement serving as another within-subjects factor (0, 1, 2, 3, 4, 5 and 6 h-post-drug. Data was analyzed separately for each drug class-drug dose condition.
Mood - Each scale of the POMS and all VAS scales save "Drug liking" were analyzed via repeated-measures ANOVA, with treatment (placebo versus drug) and time of measurement as within-subjects factors. Data was analyzed separately for each drug class and drug dose condition. The "drug liking" VAS scale was analyzed via one-way ANOVA, with drug class-drug dose conditions as between-groups factors (MDMA at 75, 110 and 145 mg/70 mg and mCPP at 17.5, 35 and 52.5 mg/70 mg).
Alterations in Consciousness - A repeated measures ANOVA was conducted on all ARCI and HRS scales, with treatment (placebo versus drug) and time of measurement both as within-subject variables. Data was analyzed for each drug class-drug dose condition separately.
Drug Identification - The post-session questionnaire was not statistically analyzed, but answers were tabulated by condition.
Results: Physiological Effects, MDMA - All doses of MDMA (75mg/70 kg, 110 mg/70 kg and 145 mg/70 kg) produced significant elevations in systolic and diastolic BP. Both lower doses significantly increased HR (compared with placebo), and there was a trend for increased HR after the highest dose (145 mg/70 kg). Peak effects appeared 1 - 3 h post-drug, and returned to baseline 6 h post-drug. Drug effects were not dose-dependent.
Physiological Effects, mCPP - There were no significant changes in BP (systolic or diastolic) or HR after any of the 3 doses of mCPP (17.5, 35 or 52 mg/70 kg).
Mood, MDMA - MDMA produced increases in the POMS anxiety, elation, friendly, and confusion scales, when compared with placebo. MDMA increased VAS scale ratings of high, stimulated, and anxiety, when compared with placebo. While not statistically examined, the effects on mood may not be dose-dependent. (For instance, compared with placebo, the lowest dose produced elation and friendliness, and the highest dose produced confusion, but not elation or friendliness). Participants reported liking 110 mg/70 kg and 145 mg/70 kg MDMA significantly more than placebo, but there was no difference in liking for the lowest dose (75 mg/70 kg) of MDMA versus placebo.
Mood, mCPP - POMS elation, arousal and confusion scores were all increased after mCPP as compared with placebo. VAS scale ratings for high, stimulated, hungry and sedated were also increased after mCPP. Casual (non-statistical) examination suggests that mCPP-induced changes in mood were dose-dependent, with more or greater changes appearing at higher doses. Effects peaked at 2 h post-drug and returned to baseline by 4 h post-drug. Ratings of drug liking for all 3 doses of mCPP were not statistically different from placebo.
Alterations in Consciousness, MDMA - When compared with placebo, MDMA produced an increase in all ARCI scales except for BG (energy) or PCAG (sedating) scores. These include A (amphetamine-like), MBG (euphoric) and LSD (dysphoric). MDMA also produced increase in all 5 HRS scores (somatic, affective, perceptual and cognitive effects, and intensity). Casual (non-statistical) examination suggests that alterations in consciousness after MDMA were not dose-dependent.
Alterations in Consciousness, mCPP - When compared to placebo, mCPP produced increases in all ARCI scale scores except for A (amphetamine-like). All HRS scale scores save cognitive effects scale were increased after mCPP. Casual (non-statistical) analysis suggests that higher doses of mCPP produced greater alterations in consciousness.
Drug Identification - Placebo - Out of the 15 individuals receiving MDMA, all correctly identified placebo. Out of the 15 receiving mCPP, 9 correctly identified placebo. Placebo was also identified as either a sedative (3) or a stimulant (2) and as an unspecified other drug by 1 / 15. MDMA - 4 / 5 individuals in each of the 3 dose conditions (12/15) identified MDMA as either an empathogen or a hallucinogen, and 1 / 5 identified each dose of MDMA as a stimulant (3/15). MCPP - Participants identified mCPP as placebo (5 of 15), a stimulant (4/15), an empathogen, (3/15), a hallucinogen (2/15) and a sedative (1/15). Identification as placebo occurred at every dose level, including the highest dose (52.5 mg/70 kg), and mCPP was only identified as a sedative at the highest dose (52.5 mg/70 kg).
Overall Effects: Both MDMA (75, 110 and 145 mg/70 kg) and mCPP (17.5, 35 and 52.5 mg/70 kg) were well-tolerated by the participants, though several participants complained of nausea after mCPP. MDMA, but not mCPP, increased BP and HR. While increase in BP was dose-dependent, increase in HR was not dose-dependent. When compared with placebo, MDMA produced elevated mood, anxiety, friendliness and confusion. Surprisingly, the 5-HT releaser mCPP also produced increased feelings of being high, stimulated and confused. People reported experiencing stimulant-like effects after MDMA and mCPP, but people also reported increased sedation and hunger after mCPP only. When compared to placebo, MDMA produced stimulant-like and hallucinogen-like effects, but not "energy" or "sedation." Participants reported similar alterations in consciousness after mCPP, but with fewer "amphetamine-like" effects. Compared with placebo, both MDMA and mCPP increased ratings on HRS scales; MDMA produced significant increases in all sub-scales, and mCPP in all sub-scales save Cognition. MDMA was consistently identified by participants as an empathogen or hallucinogen, though 1 of 5 participants at every dose level identified MDMA as a stimulant. While participants at every dose level identified mCPP as placebo, it was also identified as a stimulant, an MDMA-like drug (empathogen), a hallucinogen and a sedative.
Adverse Effects: None specifically reported for MDMA beyond increase in BP and HR. Nausea was often reported after mCPP (in an unspecified number of individuals).
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