Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans (CAM)

The University of Chicago

Status: Completed

Conditions: Substance Abuse

Treatments: Drug: placebo; Drug: methamphetamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02323048

12-2047

Details and patient eligibility

About

The aim of the study is to extend our investigations of drug-associated conditioning with healthy volunteers. The investigators have recently completed a pilot study demonstrating that subjects show an increase in self-reported preference for a visual stimulus paired with stimulant drug administration. Furthermore, our pilot data suggest that methamphetamine acts synergistically with rewards in the environment, such that this conditioning effect is facilitated by experiencing the drug in the presence of rewarding, or positive events, such as earning money. The investigators now aim to extend these findings by assessing not only self-reported preference, but also attentional and psychophysiological (electromyogram; EMG) responses to the drug-associated stimuli.

Full description

The study will consist of an orientation session following by 6 experimental study sessions. The first experimental session will consist of a "Pre-test", where baseline data regarding attentional, psychophysiological, and self-reported responses tovarious stimuli will be collected. The following 4 sessions will consist of a drug (sedative or stimulant) or placebo. During these sessions, subjects will play simple computer games, as well as complete questionnaires regarding mood and potential subjective drug effects. The subjects will then complete a "Test" session, where attentional, psychophysiological, and self-reported responses to the stimuli will be assessed, as in the first experimental session.

Enrollment: 90 patients

Sex: All

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI of 19-26kg/m, high school education,
• fluency in English,
• resting blood pressure less than140/90mmHg and consumption of less than 4 standard alcohol or caffeinated drinks per day.

Exclusion criteria

• current substance abuse or lifetime substance dependence,
• regular medication,
• history of cardiovascular illness,
• current major Axis I DSM-IV disorder (APA, 2004),
• mood disorder or psychotic symptoms within the past year.
• Shift workers and pregnant or nursing mothers will also be excluded.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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90 participants in 5 patient groups

Paired, high reward

Experimental group

Description:

All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.

Treatment:

Drug: methamphetamine

Drug: placebo

Paired, low reward

Experimental group

Description:

All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.

Treatment:

Drug: methamphetamine

Drug: placebo

Paired no reward

Experimental group

Description:

All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.

Treatment:

Drug: methamphetamine

Drug: placebo

Unpaired, high reward

Experimental group

Description:

All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.

Treatment:

Drug: methamphetamine

Drug: placebo

Unpaired, low reward

Experimental group

Description:

All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.

Treatment:

Drug: methamphetamine

Drug: placebo