Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction

Yale University

Status and phase: Terminated; Phase 1

Conditions: Cocaine Dependent Subjects

Treatments: Drug: placebo; Drug: propranolol; Drug: cocaine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01978457

1104008404

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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6 participants in 3 patient groups, including a placebo group

cocaine hydrochloride

Experimental group

Description:

cocaine hydrochloride

Treatment:

Drug: placebo

Drug: propranolol

Drug: cocaine hydrochloride

propranolol

Experimental group

Description:

propranolol

Treatment:

Drug: propranolol

Drug: cocaine hydrochloride

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: propranolol

Drug: cocaine hydrochloride