Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Cocaine Withdrawal and Pharmacotherapy Response (Carvedilol)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00566969
First received: December 3, 2007
Last updated: August 16, 2016
Last verified: August 2016

December 3, 2007
August 16, 2016
September 2007
December 2012   (final data collection date for primary outcome measure)
Percent Days Abstinent From Cocaine - Self Report [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Percent Self reported days of abstinence from any cocaine use during the 11 week trial.
To test the efficacy of an alpha- and beta -adrenergic blocker, carvedilol, in reducing cocaine use in methadone maintained cocaine users and to test whether the efficacy of carvedilol is moderated by cocaine withdrawal severity. [ Time Frame: Four years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00566969 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cocaine Withdrawal and Pharmacotherapy Response
Cocaine Withdrawal and Pharmacotherapy Response
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.
The adrenergic neurotransmission serves multiple functions including learning, emotional processing and stress response to psychological and physical challenges (Huether, 1996; Sved et al., 2001). Adrenergic transmission also mediates drug withdrawal states and stress-induced relapse to drug use (Aston-Jones et al., 2004; Stewart, 2000). Consistent with these preclinical findings, adrenergic blockers showed promise as a treatment of cocaine dependence (Kampman et al., 2001b; Kampman et al., 2006). These preliminary findings are significant because there are no proven pharmacotherapies for cocaine addiction although an estimated 2.3 million of Americans aged 12 or older are regular cocaine users (SAMHSA, 2004). The societal cost of cocaine addiction is estimated to be $45 billion in the US, suggesting that development of even modestly effective cocaine pharmacotherapies will have great economic benefits. For example, availability of a medication decreasing cocaine use by 10 percent is estimated to have $745 million economic benefit in the US alone (Cartwright, 2000). Thus, developing effective treatments for cocaine addiction is an essential goal with significant benefits both for the society and the individual.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
  • Cocaine Dependence
  • Opiate Dependence
  • Drug: sugar pill
    Subjects randomized to placebo, carvedilol 25mg or 50mg
    Other Name: placebo
  • Drug: Carvedilol 25 mg
    subjects randomized to placebo, carvedilol 25mg or 50mg
    Other Name: Coreg
  • Drug: Carvedilol 50 mg
    subjects randomized to placebo, carvedilol 25mg or 50mg
    Other Name: Coreg
  • Placebo Comparator: Sugar Pill
    To be compared to active drug
    Intervention: Drug: sugar pill
  • Active Comparator: Carvedilol 25 mg
    To be compared to placebo and Carvedilol 50 mg
    Intervention: Drug: Carvedilol 25 mg
  • Active Comparator: Carvedilol 50 mg
    To be compared to placebo and Carvedilol 25 mg
    Intervention: Drug: Carvedilol 50 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
January 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00566969
NIDA R01DA014537, R01DA014537, DPMC
Yes
No
Not Provided
Mehmet Sofuoglu, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
Yale University
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP