Interactions Between Drug Effects and Environments II

Study Overview
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Brief Summary
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The purpose of the study is to determine how associations between drugs and the places where they are experienced influence drug seeking, mood and acute drug responses.

Detailed Description
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Learned associations between drug effects and the people, places, and paraphernalia (cues) linked with drug experiences are a major barrier to the treatment of drug addiction. These links are remarkably persistent and can cause relapse to drug taking even after long periods of abstinence. They are also key features in some of the foremost theories of addiction, yet there is little clinical evidence of how these associations are formed and how they come to profoundly control behavior. The long-term goal of this research is to understand how drug cues become powerfully linked with drug experiences and their influence on mood and behavior. In the proposed project, the investigators will use a de novo conditioning paradigm to examine the influence of drug contexts on drug seeking, mood and acute drug responses. The hypothesis is that drug-paired contexts gain motivational salience, induce approach, and alter acute subjective responses to the drug.This knowledge will lead to novel treatment strategies to counteract the effects of drug cues on mood and behavior, and also to prevent relapse.

Official Title
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Drug Contextual Conditioning With in Humans: Causes and Consequences

Conditions
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Substance-Related Disorders

Intervention / Treatment
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* Behavioral: Paired
* Drug: Stimulant or sedative
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: past use of stimulants bmi 19-26 hormonal birth control for women Exclusion Criteria: current or recent (Past year) history of major axis I disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paired<br>Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room. | Behavioral: Paired<br>* Drug conditioning is assessed by pairing drug administration with a given context.<br>* Other names: Conditioned place preference;Drug: Stimulant or sedative<br>* CS+ for paired, CS0 for unpaired<br>Drug: Placebo<br>* CS- for paired, CS0 for unpaired<br>|
| Other: Unpaired<br>Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms. | Drug: Stimulant or sedative<br>* CS+ for paired, CS0 for unpaired<br>Drug: Placebo<br>* CS- for paired, CS0 for unpaired<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Time Spent in Drug-paired Room | The amount of time spent in the two testing rooms is assessed during a 10min exploration test conducted at the orientation session (pre-test) and again at the testing session (post-test). Between the pre- and post-tests, participants complete 4 drug administration sessions; 2 with 20mg MA, 2 with 0mg MA. The Paired Group always receives 20mg MA in the room they spent the least time in at pre-test, and 0mg MA in the other room. The Unpaired Group receives 20mg MA and 0mg MA once in each room. The research question is whether the Paired Group spends significantly more time in the room paired with 20mg MA in comparison to the Unpaired Group. Thus, the outcome measure is the difference in time spent in the room paired with drug administration (i.e. the room that they spent the least time in at pre-test) between pre- and post-tests (i.e., post-test time spent - pre-test time spent) which is compared between the groups. NOTE: Time spent is NOT obtained during drug administration sessions. | Measured through study completion (maximum 5 weeks). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Drug Effects | Self-reported drug effects are measured using standardized questionnaires 30min before capsule administration (baseline) and at 30min intervals after capsule administration for 4h during each drug administration session. The peak change from baseline is calculated for each session and averaged across drug and placebo sessions. A net difference is calculated by subtracting the mean peak change from baseline during placebo sessions from the mean peak change from baseline during drug (20mg MA) sessions. Outcome measure: Subjective stimulation (i.e., feeling alert, aroused, energetic) is measured using the Amphetamine scale of the Addiction Research Center Inventory. Scores range from 0-11 with greater scores indicating greater drug effects. | Self-reported drug effects are measured 30min before drug administration and at 30min intervals after drug administration for 4h during each drug administration session. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug cues