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

NCT02323048 | Completed Results

• 1 other identifier: 12-2047
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Substance Abuse

Outcome Measures

Primary Outcomes (1)

• Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire

  The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

  End of study (time 0 and approximately 4 weeks later)

Study Arms (5)

Paired, high reward

EXPERIMENTAL

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.

Drug: methamphetamine; Drug: placebo

Paired, low reward

EXPERIMENTAL

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.

Drug: methamphetamine; Drug: placebo

Paired no reward

EXPERIMENTAL

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.

Drug: methamphetamine; Drug: placebo

Unpaired, high reward

EXPERIMENTAL

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.

Drug: methamphetamine; Drug: placebo

Unpaired, low reward

EXPERIMENTAL

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.

Drug: methamphetamine; Drug: placebo

Interventions

methamphetamine 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.

Also known as: desoxyn

Paired no reward; Paired, high reward; Paired, low reward; Unpaired, high reward; Unpaired, low reward

placebo DRUG

Placebo (sugar pill)

Also known as: dextrose

Paired no reward; Paired, high reward; Paired, low reward; Unpaired, high reward; Unpaired, low reward

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Methamphetamine; Glucose

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Dr. Harriet de Wit
• Organization: University of Chicago

dewitlab@yoda.bsd.uchicago.edu

773-702-3560

Study Officials

• Leah Mayo

  Graduate Student

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: December 23, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 26, 2018
• Results First Posted: July 26, 2018

Record last verified: 2018-06