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Behavioral Effects of Drugs (Inpatient): 38

NCT03954938 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-05-23

Study results available
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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

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.

Sponsors & Collaborators

  • William Stoops

    lead OTHER

Principal Investigators

  • William W Stoops, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2021-12-03
Completion
2021-12-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03954938 on ClinicalTrials.gov