Clinical trial NCT03954938: Behavioral Effects of Drugs (Inpatient): 38
Official title: Influence of Craving Manipulation on Cocaine Self-Administration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Cocaine Use, Unspecified
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


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

Primary outcomes:
measure: Number of Times Cocaine Was Selected
timeFrame: One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.
Secondary outcomes:
measure: Cocaine Craving
timeFrame: Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Laboratory of Human Behavioral Pharmacology
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: William W Stoops, PhD
role: PRINCIPAL_INVESTIGATOR
References: