Behavioral Effects of Drugs (Inpatient): 38

Early Phase 1

Terminated

• Conditions: Cocaine Use, Unspecified
• Interventions: Behavioral: Craving Manipulation; Drug: Cocaine; Drug: Placebo

• Registration Number: NCT03954938
• Lead Sponsor: William Stoops

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-03
• Results First Submitted: 2022-04-27
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Results First Posted: 2024-05-23
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Current cocaine use

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Neutral-Look	Craving Manipulation	Subjects will be instructed to look at cocaine associated images and respond naturally.
Negative	Placebo	Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown.
Positive	Craving Manipulation	Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown.
Positive	Placebo	Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown.
Neutral-Look	Placebo	Subjects will be instructed to look at cocaine associated images and respond naturally.
Negative	Craving Manipulation	Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown.
Positive	Cocaine	Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown.
Neutral-Look	Cocaine	Subjects will be instructed to look at cocaine associated images and respond naturally.
Negative	Cocaine	Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown.

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Cocaine Craving	Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.	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).

Trial Locations

Locations (1)

University of Kentucky Laboratory of Human Behavioral Pharmacology; 🇺🇸 Lexington, Kentucky, United States