Overview

This trial is active, not recruiting.

Condition cocaine dependent subjects
Treatments cocaine hydrochloride, propranolol, placebo
Phase phase 1
Sponsor Yale University
Start date October 2012
End date August 2017
Trial size 24 participants
Trial identifier NCT01978457, 1104008404

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
cocaine hydrochloride
cocaine hydrochloride
propranolol
placebo
(Experimental)
propranolol
cocaine hydrochloride
propranolol
(Placebo Comparator)
placebo
cocaine hydrochloride
propranolol

Primary Outcomes

Measure
Total number of patient controlled analgesic (PCA) pump activations (responses)
time frame: 3 days

Eligibility Criteria

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

Additional Information

Official title Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Yale University.