Cocaine Dependent Subjects Clinical Trial
Official title:
Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction
| Verified date | February 2020 |
| Source | Yale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 6 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: 1. Age 18 - 50 years 2. voluntary, written, informed consent 3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations 4. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20) 5. recent street cocaine use in excess of that administered in the current study 6. intravenous and/or smoked (crack/freebase) use 7. positive urine toxicology screen for cocaine 8. 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 9. able to read English and complete study evaluations. Exclusion Criteria: 1. Other drug dependence (except nicotine) 2. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine 3. 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) 4. current use of psychotropic and/or potentially psychoactive prescription medication 5. seeking treatment for drug abuse/dependence 6. 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Connecticut Mental Health Center | New Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Yale University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total number of patient controlled analgesic (PCA) pump activations (responses) | 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). | 3 days |