Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: cocaine hydrochloride cocaine hydrochloride |
Drug: cocaine hydrochloride
Drug: propranolol
Drug: placebo
|
| Experimental: propranolol propranolol |
Drug: cocaine hydrochloride
Drug: propranolol
|
| Placebo Comparator: placebo placebo |
Drug: cocaine hydrochloride
Drug: propranolol
|
Outcome Measures
Primary Outcome Measures
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 - 50 years
-
voluntary, written, informed consent
-
physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
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DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
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recent street cocaine use in excess of that administered in the current study
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intravenous and/or smoked (crack/freebase) use
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positive urine toxicology screen for cocaine
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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
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able to read English and complete study evaluations.
Exclusion Criteria:
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Other drug dependence (except nicotine)
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a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine
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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)
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current use of psychotropic and/or potentially psychoactive prescription medication
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seeking treatment for drug abuse/dependence
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Connecticut Mental Health Center | New Haven | Connecticut | United States | 06519 |
Sponsors and Collaborators
- Yale University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1104008404