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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT03954938
Status
Suspended
Sponsor
William Stoops

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.