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

NCT ID: NCT02323048

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

Detailed 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.

Conditions

Substance Abuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Paired, high reward

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.

Group Type: EXPERIMENTAL

methamphetamine

Intervention Type: DRUG

: Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.

placebo

Intervention Type: DRUG

Placebo (sugar pill)

Paired, low reward

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.

Group Type: EXPERIMENTAL

methamphetamine

Intervention Type: DRUG

: Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.

placebo

Intervention Type: DRUG

Placebo (sugar pill)

Paired no reward

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.

Group Type: EXPERIMENTAL

methamphetamine

Intervention Type: DRUG

: Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.

placebo

Intervention Type: DRUG

Placebo (sugar pill)

Unpaired, high reward

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.

Group Type: EXPERIMENTAL

methamphetamine

Intervention Type: DRUG

: Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.

placebo

Intervention Type: DRUG

Placebo (sugar pill)

Unpaired, low reward

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.

Group Type: EXPERIMENTAL

methamphetamine

Intervention Type: DRUG

: Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.

placebo

Intervention Type: DRUG

Placebo (sugar pill)

Interventions

methamphetamine

: Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.

Intervention Type: DRUG

placebo

Placebo (sugar pill)

Intervention Type: DRUG

Other Intervention Names

desoxyn; dextrose

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leah Mayo

Role: STUDY_DIRECTOR

Graduate Student

Other Identifiers

12-2047

Identifier Type: -

Identifier Source: org_study_id