Behavioral Effects of Drugs (Inpatient): 38

William Stoops

Status and phase: Terminated; Early Phase 1

Conditions: Cocaine Use, Unspecified

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03954938

BED In 38

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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5 participants in 3 patient groups

Neutral-Look

Sham Comparator group

Description:

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

Treatment:

Drug: Cocaine

Drug: Placebo

Behavioral: Craving Manipulation

Positive

Experimental group

Description:

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

Treatment:

Drug: Cocaine

Drug: Placebo

Behavioral: Craving Manipulation

Negative

Active Comparator group

Description:

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

Treatment:

Drug: Cocaine

Drug: Placebo

Behavioral: Craving Manipulation