Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction

NCT01978457 | Terminated Phase 1

• 1 other identifier: 1104008404
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependent Subjects

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

cocaine hydrochloride

EXPERIMENTAL

cocaine hydrochloride

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

propranolol

EXPERIMENTAL

propranolol

Drug: cocaine hydrochloride; Drug: propranolol

placebo

PLACEBO COMPARATOR

placebo

Drug: cocaine hydrochloride; Drug: propranolol

Interventions

cocaine hydrochloride DRUG

cocaine hydrochloride; placebo; propranolol

propranolol DRUG

cocaine hydrochloride; placebo; propranolol

placebo DRUG

cocaine hydrochloride

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 50 years
• voluntary, written, informed consent
• physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
• DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
• recent street cocaine use in excess of that administered in the current study
• intravenous and/or smoked (crack/freebase) use
• positive urine toxicology screen for cocaine
• 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
• able to read English and complete study evaluations.

You may not qualify if:

• Other drug dependence (except nicotine)
• a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine
• 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)
• current use of psychotropic and/or potentially psychoactive prescription medication
• seeking treatment for drug abuse/dependence
• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Interventions

Cocaine; Propranolol

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: November 7, 2013
• Study Start: October 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

US (1)