Behavioral Effects of Drugs (Inpatient): 38

Influence of Craving Manipulation on Cocaine Self-Administration

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.

Study Overview

• Status: Terminated
• Conditions: Cocaine Use, Unspecified
• Intervention / Treatment: Behavioral: Craving Manipulation; Drug: Cocaine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40507
      • University of Kentucky Laboratory of Human Behavioral Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Neutral-Look; Subjects will be instructed to look at cocaine associated images and respond naturally.	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.
Experimental: Positive; Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown.	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.
Active Comparator: Negative; Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Times Cocaine Was Selected	The reinforcing effects of cocaine will be 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 are 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cocaine Craving	Cocaine craving will be 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).	Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.

Collaborators and Investigators

• Sponsor: William Stoops

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): December 3, 2021
• Study Completion (Actual): December 3, 2021

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Anesthetics, Local; Dopamine Uptake Inhibitors; Vasoconstrictor Agents; Cocaine
• Other Study ID Numbers: BED In 38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No