Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction
- Conditions
- Cocaine Dependent Subjects
- Interventions
- Registration Number
- NCT01978457
- Lead Sponsor
- Yale University
- Brief Summary
We will develop a procedure for conditioning cue-cocaine associations in human drug users. Next, we will reactivate that learning and intervene pharmacologically to prevent the reconsolidation of cue-drug memories. We hypothesize that a combined behavioral and pharmacological approach will have significant potential for persistently inhibiting relapse.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- Age 18 - 50 years
- voluntary, written, informed consent
- physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
- DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
- recent street cocaine use in excess of that administered in the current study
- intravenous and/or smoked (crack/freebase) use
- positive urine toxicology screen for cocaine
- for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (-HCG) test
- able to read English and complete study evaluations.
- Other drug dependence (except nicotine)
- a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine
- a history of significant medical (cardiovascular) or neurological illness (e.g., prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrythmias of clinical significance, and/or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures)
- current use of psychotropic and/or potentially psychoactive prescription medication
- seeking treatment for drug abuse/dependence
- those having contraindications to beta-blocker administration, including diagnoses of asthma, bronchitis, emphysema, or a history of adverse reactions to beta-blockers (including propranolol), as well as those with bradycardia and/or first-degree or greater heart block by ECG
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description placebo cocaine hydrochloride placebo propranolol cocaine hydrochloride propranolol cocaine hydrochloride cocaine hydrochloride cocaine hydrochloride cocaine hydrochloride placebo cocaine hydrochloride propranolol propranolol propranolol placebo propranolol placebo cocaine hydrochloride propranolol cocaine hydrochloride
- Primary Outcome Measures
Name Time Method Total number of patient controlled analgesic (PCA) pump activations (responses) 3 days Data on cocaine self-administration (total number of responses) will be checked for normality prior to analysis using Kolmogorov-Smirnov statistics and normal probability plots. Data that is not normally distributed will be log transformed. If it remains highly skewed after transformation, it will be analyzed using non-parametric approaches (e.g., a non-parametric, ANOVA-Type Statistic). Normally distributed data will be analyzed employing a mixed model design, 3-way ANOVA with co-factors of placebo vs propranolol (between subjects), non-cocaine predicting cues vs. cocaine predicting cues (within subjects) and non-reactivated cocaine cues vs. reactivated cocaine cues (within subjects).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Connecticut Mental Health Center
🇺🇸New Haven, Connecticut, United States