Behavioral Effects of Drugs (Inpatient): 38
Purpose
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.
Condition
- Cocaine Use, Unspecified
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Sham Comparator Neutral-Look |
Subjects will be instructed to look at cocaine associated images and respond naturally. |
|
Experimental Positive |
Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown. |
|
Active Comparator Negative |
Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown. |
|
Recruiting Locations
More Details
- NCT ID
- NCT03954938
- Status
- Terminated
- Sponsor
- William Stoops