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Behavioral Effects of Drugs (Inpatient): 38

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03954938
Recruitment Status : Suspended (COVID-19)
First Posted : May 17, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
William Stoops, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Cocaine Use, Unspecified Behavioral: Craving Manipulation Drug: Cocaine Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Craving Manipulation on Cocaine Self-Administration
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of Times Cocaine Was Selected [ Time Frame: One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation. ]
    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.


Secondary Outcome Measures :
  1. Cocaine Craving [ Time Frame: Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation. ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954938


Locations
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United States, Kentucky
University of Kentucky Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, United States, 40507
Sponsors and Collaborators
William Stoops
Investigators
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Principal Investigator: William W Stoops, PhD University of Kentucky
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Responsible Party: William Stoops, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03954938    
Other Study ID Numbers: BED In 38
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents