NCT03954938

Behavioral Effects of Drugs (Inpatient): 38

Influence of Craving Manipulation on Cocaine Self-Administration

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: William Stoops · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cocaine Use, Unspecified

Interventions

Type	Name	Description
BEHAVIORAL	Craving Manipulation	Craving will be manipulated based on instructions about cocaine associated images shown to subjects.
DRUG	Cocaine	The pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition.
DRUG	Placebo	The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition.

Timeline

• Start date: 2019-05-15
• Primary completion: 2021-12-03
• Completion: 2021-12-03
• First posted: 2019-05-17
• Last updated: 2024-05-23
• Results posted: 2024-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study