Clinical trial

Influence of Craving Manipulation on Cocaine Self-Administration

Name
BED In 38
Description
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.
Trial arms
Trial start
2019-05-15
Estimated PCD
2021-12-03
Trial end
2021-12-03
Status
Terminated
Phase
Early phase I
Treatment
Craving Manipulation
Craving will be manipulated based on instructions about cocaine associated images shown to subjects.
Arms:
Negative, Neutral-Look, Positive
Cocaine
The pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition.
Arms:
Negative, Neutral-Look, Positive
Placebo
The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition.
Arms:
Negative, Neutral-Look, Positive
Size
5
Primary endpoint
Number of Times Cocaine Was Selected
One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}
Updated at
2024-05-23

1 organization

1 product

1 drug

2 indications

Organization
William Stoops
Product
Cocaine
Indication
Cocaine Use
Indication
Unspecified