Cocaine Withdrawal and Pharmacotherapy Response (Carvedilol)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00566969
First received: December 3, 2007
Last updated: December 12, 2013
Last verified: December 2013

December 3, 2007
December 12, 2013
September 2007
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
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 20 male and female opioid dependent cocaine users will participate in this study. This study will be a 8 -week open label study examining the dose-dependent effects of carvedilol (up to 50mg/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 140mg/day). Carvedilol dose will be increased from 12.5mg/day to the target dose of 50mg/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.

This study has 77 completers and currently in data analysis.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Cocaine Addictions
  • Drug: sugar pill
    randomly given 25mg or 50mg of a sugar pill or the active comparator
    Other Name: sugar pill
  • Drug: carvedilol
    randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
    Other Name: carvedilol
  • Drug: Methadone
    Maintenance
  • Placebo Comparator: Sugar Pill
    To be compared to active drug
    Intervention: Drug: sugar pill
  • Active Comparator: Carvedilol
    To be compared to sugar pill
    Intervention: Drug: carvedilol
  • Methadone
    reduce opiate use
    Intervention: Drug: Methadone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
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 12month 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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00566969
NIDA R01DA014537, R01DA014537, DPMC
Yes
Mehmet Sofuoglu, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
Yale University
December 2013

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