Behavioral Effects of Drugs (Inpatient): 38

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2021-12-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Cocaine Use, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Neutral-Look

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

Group Type SHAM_COMPARATOR

Craving Manipulation

Intervention Type BEHAVIORAL

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

Cocaine

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Positive

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

Group Type EXPERIMENTAL

Craving Manipulation

Intervention Type BEHAVIORAL

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

Cocaine

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Negative

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

Group Type ACTIVE_COMPARATOR

Craving Manipulation

Intervention Type BEHAVIORAL

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

Cocaine

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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Craving Manipulation

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

Intervention Type BEHAVIORAL

Cocaine

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes