Cocaine Withdrawal and Pharmacotherapy Response

NCT00566969 | Completed Results DMC

• 3 other identifiers: 0704002562R01DA014537DPMC
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 120 male and female opioid dependent cocaine users will participate in this study. This study will be a 8-week double-blind, placebo controlled study examining the dose-dependent effects of carvedilol (up to 50 mg/day) in methadone stabilized patients. The design will have two phases: 1) a four-week "treatment " phase; and 2) a 4 week " taper and detoxification or transfer" phase. Subjects will be cocaine users who are on stable doses of methadone (60 to 140 mg/day). Carvedilol dose will be increased from 12.5mg/day to the target dose of either 25 or 50 mg/day as tolerated. At the end of the treatment-phase, subjects will undergo detoxification from methadone over a 2 to 4-week period based on an individual's needs, and they will concurrently be tapered off carvedilol.

Conditions

Cocaine Dependence; Opiate Dependence

Keywords

cocaine, opiate, methadone, carvedilol

Outcome Measures

Primary Outcomes (1)

• Percent Days Abstinent From Cocaine - Self Report

  Percent Self reported days of abstinence from any cocaine use during the 11 week trial.

  11 weeks

Study Arms (3)

Sugar Pill

PLACEBO COMPARATOR

To be compared to active drug

Drug: sugar pill

Carvedilol 25 mg

ACTIVE COMPARATOR

To be compared to placebo and Carvedilol 50 mg

Drug: Carvedilol 25 mg

Carvedilol 50 mg

ACTIVE COMPARATOR

To be compared to placebo and Carvedilol 25 mg

Drug: Carvedilol 50 mg

Interventions

sugar pill DRUG

Subjects randomized to placebo, carvedilol 25mg or 50mg

Also known as: placebo

Sugar Pill

Carvedilol 25 mg DRUG

subjects randomized to placebo, carvedilol 25mg or 50mg

Also known as: Coreg

Carvedilol 25 mg

Carvedilol 50 mg DRUG

subjects randomized to placebo, carvedilol 25mg or 50mg

Also known as: Coreg

Carvedilol 50 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current opioid dependence as evidenced by documented prior treatment for opioid dependence or signs of opiate withdrawals, self-reported history of opioid dependence for a consecutive 12 month period and a positive urine for opiates.
• Current cocaine use with self-reported use of cocaine \> 1 time/week in at least on month preceding study entry, provision of a cocaine-positive urine and fulfilled DSM-IV criteria for cocaine dependence
• For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.

You may not qualify if:

• current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco);
• serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, hepatic disorders;
• current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts;
• screening liver function tests (AST or ALT) greater than 3 times normal;
• known allergy or intolerance for carvedilol or methadone.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Veterans Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Opioid-Related Disorders

Interventions

Sugars; Carvedilol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Mehmet Sofuoglu, M.D.,Ph.D.
• Organization: Yale University

mehmet.sofuoglu@yale.edu

203-932-5711

Study Officials

• Mehmet Sofuoglu, M.D., Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 4, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 2, 2020
• Results First Posted: October 10, 2016

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)