Behavioral Effects of Drugs (Inpatient): 38

Study Overview
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Brief Summary
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The specific aim of this project is to demonstrate that the decisional analysis/craving regulation aspects of CBT reduce cocaine self-administration in subjects with cocaine use disorder through diminished craving responses. Thirty non-treatment seeking human subjects meeting diagnostic criteria for cocaine use disorder will complete an outpatient, crossover, placebo-controlled study consisting of 1 practice and 9 experimental sessions. In each experimental session, the reinforcing effects of intranasal cocaine will be determined under one of three regulation of craving conditions that simulate CBT decisional analysis (i.e., negative instruction, positive instruction or a neutral look condition). After sampling the dose of cocaine available in each session, subjects will complete the craving manipulation assigned to that session, they will then rate their craving and finally they will have the opportunity to earn the sampled dose in a progressive-ratio procedure. We hypothesize that focusing on the negative effects of cocaine use will decrease craving and reduce cocaine self-administration relative to the positive and look conditions, and that craving will be positively correlated with self-administration outcomes.

Official Title
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Influence of Craving Manipulation on Cocaine Self-Administration

Conditions
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Cocaine Use, Unspecified

Intervention / Treatment
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* Behavioral: Craving Manipulation
* Drug: Cocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current cocaine use Exclusion Criteria: Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant Current or past histories of substance use disorder that are deemed by the study physicians to interfere with study completion History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation Females not currently using effective birth control Contraindications to cocaine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Neutral-Look<br>Subjects will be instructed to look at cocaine associated images and respond naturally. | Behavioral: Craving Manipulation<br>* Craving will be manipulated based on instructions about cocaine associated images shown to subjects.<br>Drug: Cocaine<br>* The pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition.<br>Drug: Placebo<br>* The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition.<br>|
| Experimental: Positive<br>Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown. | Behavioral: Craving Manipulation<br>* Craving will be manipulated based on instructions about cocaine associated images shown to subjects.<br>Drug: Cocaine<br>* The pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition.<br>Drug: Placebo<br>* The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition.<br>|
| Active Comparator: Negative<br>Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown. | Behavioral: Craving Manipulation<br>* Craving will be manipulated based on instructions about cocaine associated images shown to subjects.<br>Drug: Cocaine<br>* The pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition.<br>Drug: Placebo<br>* The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Times Cocaine Was Selected | The reinforcing effects of cocaine will be determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects can make 5 choices for each available cocaine dose. Reinforcing effects are measured for each cocaine dose during across the craving manipulation conditions. | One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine Craving | Cocaine craving will be assessed using a 10 point craving questionnaire that asks subjects to rate how much they are craving cocaine at that moment. The minimum craving score is 0 (i.e., no craving), the maximum craving score is 10 (i.e., highest craving). | Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation. |