Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction
This trial is active, not recruiting.
|Condition||cocaine dependent subjects|
|Treatments||cocaine hydrochloride, propranolol, placebo|
|Start date||October 2012|
|End date||August 2017|
|Trial size||24 participants|
|Trial identifier||NCT01978457, 1104008404|
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.
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
|Primary purpose||basic science|
Total number of patient controlled analgesic (PCA) pump activations (responses)
time frame: 3 days
Male or female participants from 18 years up to 50 years old.
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
|Official title||Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction|
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