Cocaine Use, Unspecified Clinical Trial
Official title:
Influence of Craving Manipulation on Cocaine Self-Administration
| Verified date | April 2024 |
| Source | University of Kentucky |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | December 3, 2021 |
| Est. primary completion date | December 3, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Kentucky Laboratory of Human Behavioral Pharmacology | Lexington | Kentucky |
| Lead Sponsor | Collaborator |
|---|---|
| William Stoops |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Times Cocaine Was Selected | The reinforcing effects of cocaine were 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 were 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 | Cocaine Craving | Cocaine craving was 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. |