Behavioral Effects of Drugs (Inpatient): 38

NCT03954938 | Terminated Early Phase 1 Results FDA Drug

• 1 other identifier: BED In 38
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Use, Unspecified

Outcome Measures

Primary Outcomes (1)

• Number of Times Cocaine Was Selected

  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.

  One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.

Secondary Outcomes (1)

• Cocaine Craving

  Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.

Study Arms (3)

Neutral-Look

SHAM COMPARATOR

Subjects will be instructed to look at cocaine associated images and respond naturally.

Behavioral: Craving Manipulation; Drug: Cocaine; Drug: Placebo

Positive

EXPERIMENTAL

Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown.

Behavioral: Craving Manipulation; Drug: Cocaine; Drug: Placebo

Negative

ACTIVE COMPARATOR

Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown.

Behavioral: Craving Manipulation; Drug: Cocaine; Drug: Placebo

Interventions

Craving Manipulation BEHAVIORAL

Craving will be manipulated based on instructions about cocaine associated images shown to subjects.

Negative; Neutral-Look; Positive

Cocaine DRUG

The pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition.

Negative; Neutral-Look; Positive

Placebo DRUG

The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition.

Negative; Neutral-Look; Positive

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current cocaine use

You may not qualify if:

• 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

Sponsors & Collaborators

• William Stoops: lead

Study Sites (1)

University of Kentucky Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, 40507, United States

Location

MeSH Terms

Interventions

Cocaine

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed; only completing subjects' data analyzed due to within subjects design.

Results Point of Contact

• Title: William W. Stoops
• Organization: University of Kentucky

william.stoops@uky.edu

8592575388

Study Officials

• William W Stoops, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: May 15, 2019
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: May 23, 2024
• Results First Posted: May 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)