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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans: Self-report, Behavioral, and Psychophysiological Measures.

Conditions
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Substance Abuse

Intervention / Treatment
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* Drug: methamphetamine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paired, high reward<br>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<br>* : 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.<br>* Other names: desoxyn;Drug: placebo<br>* Placebo (sugar pill)<br>* Other names: dextrose;|
| Experimental: Paired, low reward<br>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<br>* : 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.<br>* Other names: desoxyn;Drug: placebo<br>* Placebo (sugar pill)<br>* Other names: dextrose;|
| Experimental: Paired no reward<br>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<br>* : 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.<br>* Other names: desoxyn;Drug: placebo<br>* Placebo (sugar pill)<br>* Other names: dextrose;|
| Experimental: Unpaired, high reward<br>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<br>* : 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.<br>* Other names: desoxyn;Drug: placebo<br>* Placebo (sugar pill)<br>* Other names: dextrose;|
| Experimental: Unpaired, low reward<br>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<br>* : 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.<br>* Other names: desoxyn;Drug: placebo<br>* Placebo (sugar pill)<br>* Other names: dextrose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |