HealthyTDSNCT02485158

Individual Differences in the Response to Drugs

A study testing THC, AMP and ALC in people with Healthy, run by University of Chicago.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: THC, AMP and ALC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: No sites listed yet
Study dates: Jul 2013to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

About this study

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

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.

Read the detailed description

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.

Conditions: Healthy
Being tested: THC, AMP, ALC, Placebo capsules, Placebo beverage
Keywords: Subjective Effects, Alcohol, Amphetamine, THC, Personality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

THCDrug
Also called delta-9-tetrahydrocannabinol
This is a within-subjects, double-blind, placebo controlled design. We administered oral THC to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
AMPDrug
Also called d-Amphetamine
This is a within-subjects, double-blind, placebo controlled design. We administered AMP to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
ALCDrug
Also called Alcohol
This is a within-subjects, double-blind, placebo controlled design. We administered alcohol to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
Placebo capsulesDrug
Also called Sugar Pills
This is a within-subjects, double-blind, placebo controlled design. We administered size 00 gelatin capsules containing dextrose to healthy volunteers as a control for when they received either amphetamine or THC.
Placebo beverageDrug
This is a within-subjects, double-blind, placebo controlled design. We administered a drink containing cranberry juice plus 1% alcohol added as a taste mask.

Study groups in NCT02485158
Study group	Role	What they receive
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. Receives: Drug: THC; Drug: AMP; Drug: ALC; Drug: Placebo capsules; Drug: Placebo beverage
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. Receives: Drug: THC; Drug: AMP; Drug: ALC; Drug: Placebo capsules; Drug: Placebo beverage

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule 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.
Measured: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration
Change in General Drug Effects (Drug Effects Questionnaire) at 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.
Measured: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.
Change in General Drug Effects (Drug Effects Questionnaire) at 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.
Measured: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.
Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion
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.
Measured: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.
Change in General Drug Effects (Drug Effects Questionnaire) at 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.
Measured: Measured 15 minutes prior to capsule administration and 150 minutes after drink administration.
Change in General Drug Effects (Drug Effects Questionnaire) at 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.
Measured: Measured 15 minutes prior to capsule administration and 180 minutes after drink administration.
Change in General Drug Effects (Drug Effects Questionnaire) at 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.
Measured: Measured 15 minutes prior to capsule administration and 210 minutes after drink administration.
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule 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.
Measured: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration
Change in Specific Drug Effects (Addiction Research Center Inventory) at 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.
Measured: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration
Change in Specific Drug Effects (Addiction Research Center Inventory) at 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.
Measured: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration
Change in Specific Drug Effects (Addiction Research Center Inventory) at 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.
Measured: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration
Change in Specific Drug Effects (Addiction Research Center Inventory) at 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.
Measured: Measured 15 minutes prior to capsule administration and 150 minutes after drink administration
Change in Specific Drug Effects (Addiction Research Center Inventory) at 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.
Measured: Measured 15 minutes prior to capsule administration and 180 minutes after drink administration
Change in Specific Drug Effects (Addiction Research Center Inventory) at 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.
Measured: Measured 15 minutes prior to capsule administration and 210 minutes after drink administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Dec 2013

First posted30 Jun 2015 (estimated)
Study startJul 2013
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02485158
Sponsor's protocol ID: IRB13-0534
Acronym: TDS
Status last verified: Oct 2016
First submitted: 24 Jun 2015
Last updated: 29 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wardle MC, Marcus BA, de Wit H. A Preliminary Investigation of Individual Differences in Subjective Responses to D-Amphetamine, Alcohol, and Delta-9-Tetrahydrocannabinol Using a Within-Subjects Randomized Trial. PLoS One. 2015 Oct 29;10(10):e0140501. doi: 10.1371/journal.pone.0140501. eCollection 2015.
PubMed 26513587

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Preliminary Investigation of Individual Differences in Subjective Responses to D-amphetamine, Alcohol, and Delta-9-tetrahydrocannabinol
ClinicalTrials.gov ID: NCT02485158
Acronym / sponsor ID: TDS / IRB13-0534
Conditions: Healthy
Keywords: Subjective Effects, Alcohol, Amphetamine, THC, Personality
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: Jul 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 30 Jun 2015 (estimated)
Results: Posted 29 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AMP, ALC, THC or Placebo 1	Experimental	Drug: THC, Drug: AMP, Drug: ALC, Drug: Placebo capsules, Drug: Placebo beverageAll 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.
AMP, ALC, THC or Placebo 2	Experimental	Drug: THC, Drug: AMP, Drug: ALC, Drug: Placebo capsules, Drug: Placebo beverageAll 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.

Who may qualify

Ages: 21 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
THCAlso: delta-9-tetrahydrocannabinolThis is a within-subjects, double-blind, placebo controlled design. We administered oral THC to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.	Drug	AMP, ALC, THC or Placebo 1, AMP, ALC, THC or Placebo 2
AMPAlso: d-AmphetamineThis is a within-subjects, double-blind, placebo controlled design. We administered AMP to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.	Drug	AMP, ALC, THC or Placebo 1, AMP, ALC, THC or Placebo 2
ALCAlso: AlcoholThis is a within-subjects, double-blind, placebo controlled design. We administered alcohol to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.	Drug	AMP, ALC, THC or Placebo 1, AMP, ALC, THC or Placebo 2
Placebo capsulesAlso: Sugar PillsThis is a within-subjects, double-blind, placebo controlled design. We administered size 00 gelatin capsules containing dextrose to healthy volunteers as a control for when they received either amphetamine or THC.	Drug	AMP, ALC, THC or Placebo 1, AMP, ALC, THC or Placebo 2
Placebo beverageThis is a within-subjects, double-blind, placebo controlled design. We administered a drink containing cranberry juice plus 1% alcohol added as a taste mask.	Drug	AMP, ALC, THC or Placebo 1, AMP, ALC, THC or Placebo 2

Primary outcome

Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration
Time frame: 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
Time frame: 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 90 Minutes After Drink Administration
Time frame: 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 General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 90 Minutes After Drink Administration
Time frame: 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
Time frame: 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 Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration
Time frame: 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 180 Minutes After Drink Administration
Time frame: 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 210 Minutes After Drink Administration
Time frame: 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.

Results and safety

Results posted to the registry on 29 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Adult Volunteers	28	24

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

Time frame: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration. Mean (Standard Deviation). Unit: units on a scale

Measure	AMP Arm n = 24	ALC Arm n = 24	THC Arm n = 24	AMP Placebo Arm n = 24	ALC Placebo Arm n = 24	THC Placebo Arm n = 24
DEQ Feel	4.79 (7.22)	12.83 (18.78)	11.08 (21.09)	12.17 (19.90)	9.38 (11.12)	4.5 (13.16)
DEQ Like	16.08 (27.47)	18.67 (28.81)	11.75 (21.84)	9.0 (18.42)	10.04 (17.90)	9.67 (24.14)
DEQ Dislike	4.21 (9.43)	11.71 (20.35)	12.38 (23.77)	10.71 (18.75)	11.0 (20.60)	0.83 (2.24)
DEQ High	3.29 (6.06)	8.83 (16.31)	10.58 (21.85)	6.96 (18.44)	5.5 (10.43)	3.67 (9.40)
DEQ More	14.21 (25.26)	13.5 (25.24)	6.54 (13.71)	5.63 (12.59)	3.71 (7.66)	11.0 (25.32)

Population analysed: Participants who completed all sessions

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

Time frame: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.. Mean (Standard Deviation). Unit: units on a scale

Measure	AMP Arm n = 24	ALC Arm n = 24	THC Arm n = 24	AMP Placebo Arm n = 24	ALC Placebo Arm n = 24	THC Placebo Arm n = 24
DEQ Feel	43.42 (29.53)	76.83 (20.01)	38.25 (33.45)	21.58 (19.52)	17.83 (22.56)	18.63 (20.69)
DEQ Like	53.88 (34.49)	45.08 (28.43)	28.75 (30.05)	16.63 (22.89)	14.38 (20.78)	25.29 (28.76)
DEQ Dislike	15.71 (22.76)	43.96 (28.96)	25.63 (35.03)	17.71 (23.32)	16.68 (26.83)	15.79 (20.66)
DEQ High	30.5 (27.78)	50.38 (32.15)	31.75 (35.00)	12.54 (18.09)	11.5 (21.80)	12.96 (20.22)
DEQ More	42.17 (35.27)	24.75 (32.67)	17.46 (25.18)	10.96 (19.14)	10.0 (18.32)	18.96 (28.97)

Population analysed: Participants who completed all sessions

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

Time frame: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.. Mean (Standard Deviation). Unit: units on a scale

Measure	AMP Arm n = 24	ALC Arm n = 24	THC Arm n = 24	AMP Placebo Arm n = 24	ALC Placebo Arm n = 24	THC Placebo Arm n = 24
DEQ Feel	34.92 (24.75)	61.21 (24.02)	31.54 (31.41)	16.46 (18.97)	12.75 (18.74)	13.17 (19.05)
DEQ Like	55.67 (31.45)	29.92 (28.57)	20.08 (26.32)	10.42 (18.22)	11.38 (19.35)	13.25 (22.87)
DEQ Dislike	16.54 (21.60)	50.46 (26.47)	23.25 (29.72)	17.54 (26.16)	15.33 (24.85)	15.96 (24.91)
DEQ High	27.92 (24.57)	41.83 (30.74)	29.21 (32.78)	6.83 (12.47)	7.25 (13.50)	7.58 (12.65)
DEQ More	50.21 (36.06)	25.88 (35.11)	16.54 (23.69)	6.54 (15.33)	7.71 (16.59)	12.88 (21.88)

Population analysed: Participants who completed all sessions

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

Time frame: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.. Mean (Standard Deviation). Unit: units on a scale

Measure	AMP Arm n = 24	ALC Arm n = 24	THC Arm n = 24	AMP Placebo Arm n = 24	ALC Placebo Arm n = 24	THC Placebo Arm n = 24
DEQ Feel	27.08 (22.38)	43.92 (24.18)	24.08 (29.28)	11.92 (14.26)	7.96 (14.08)	7.88 (14.65)
DEQ Like	43.75 (36.08)	23.79 (25.61)	18 (27.26)	7.04 (13.90)	4.83 (11.49)	8.67 (16.86)
DEQ Dislike	11.92 (19.56)	44.92 (31.37)	19.63 (27.21)	13.38 (22.39)	11.08 (23.89)	8.88 (18.69)
DEQ High	18.88 (21.43)	29.38 (25.77)	21.96 (30.06)	5.04 (8.12)	5.08 (11.20)	4.83 (10.45)
DEQ More	45.38 (34.86)	17.5 (27.95)	9.92 (18.06)	3.13 (5.53)	6.54 (15.59)	9.88 (19.63)

Population analysed: Participants who completed all sessions

Adverse events

Time frame: During study only (1 Day). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Adult Volunteers	0 of 28 (0%)	1 of 28 (3.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26513587Wardle MC, Marcus BA, de Wit H. A Preliminary Investigation of Individual Differences in Subjective Responses to D-Amphetamine, Alcohol, and Delta-9-Tetrahydrocannabinol Using a Within-Subjects Randomized Trial. PLoS One. 2015 Oct 29;10(10):e0140501. doi: 10.1371/journal.pone.0140501. eCollection 2015.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Harriet de Wit, PhD principal investigator

University of Chicago

Questions about this trial

What is this clinical trial studying?

A study testing THC, AMP and ALC in people with Healthy, run by University of Chicago.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration (time frame: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02485158, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.