跳至主要内容
临床试验/NCT02485158
NCT02485158已完成不适用

A Preliminary Investigation of Individual Differences in Subjective Responses to D-amphetamine, Alcohol, and Delta-9-tetrahydrocannabinol

University of Chicago0 个研究点目标入组 28 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
28
主要终点
Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration

研究概览

简要总结

The purpose of this study is to examine whether individual differences in acute responses to drugs co-vary across three drugs from different drug classes: alcohol, amphetamine and delta-9-tetrahydrocannabinol (THC). The investigators hypothesize that individuals who experience greater rewarding effects from one drug will also experience more rewarding effects from the other drugs.

详细描述

Here, the investigators aim to investigate whether individuals exhibit similar responses to three different drugs from different classes. This study used a within-subjects design (total N = 24). All subjects received alcohol, amphetamine and delta-9-tetrahydrocannabinol (THC) in a double-blind, double-dummy fashion. Subjects completed six sessions wherein they received either alcohol, amphetamine, or THC, or corresponding placebos, on separate days. Subjects completed questionnaires about mood, general drug effects, and specific drug effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • English fluency
  • High school education
  • BMI between 19 and 26
  • Individuals who report drinking at least 4 alcoholic drinks on one occasion in the past month

排除标准

  • individuals with a medical condition contraindicating study participation, as determined by our physician
  • individuals regularly using any contraindicated medications
  • individuals with current dependence on any drug or past dependence on alcohol, marijuana or stimulants
  • individuals with a past year DSM-IV Axis I mood, anxiety, eating, or psychotic disorder
  • women who are pregnant, nursing, or planning to become pregnant in the next 3 months
  • individuals who drink more than 10 alcoholic drinks per week
  • individuals who currently use i) any illicit drug weekly or more frequently, ii) stimulant prescription drugs, iii) more than 10 cigarettes per week, and iv) more than 3 cups of coffee per day

研究组 & 干预措施

AMP, ALC, THC or Placebo 1

Experimental

All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.

干预措施: THC (Drug)

AMP, ALC, THC or Placebo 1

Experimental

All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.

干预措施: AMP (Drug)

AMP, ALC, THC or Placebo 1

Experimental

All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.

干预措施: ALC (Drug)

AMP, ALC, THC or Placebo 1

Experimental

All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.

干预措施: Placebo capsules (Drug)

AMP, ALC, THC or Placebo 1

Experimental

All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.

干预措施: Placebo beverage (Drug)

AMP, ALC, THC or Placebo 2

Experimental

All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.

干预措施: THC (Drug)

AMP, ALC, THC or Placebo 2

Experimental

All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.

干预措施: AMP (Drug)

AMP, ALC, THC or Placebo 2

Experimental

All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.

干预措施: ALC (Drug)

AMP, ALC, THC or Placebo 2

Experimental

All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.

干预措施: Placebo capsules (Drug)

AMP, ALC, THC or Placebo 2

Experimental

All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.

干预措施: Placebo beverage (Drug)

结局指标

主要结局

Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration

时间窗: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion

时间窗: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 150 minutes after drink administration.

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 180 minutes after drink administration.

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 210 minutes after drink administration.

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration

时间窗: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 180 minutes after drink administration

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 150 minutes after drink administration

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration

时间窗: Measured 15 minutes prior to capsule administration and 210 minutes after drink administration

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验