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Cocaine Withdrawal and Pharmacotherapy Response (Carvedilol)
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), September 2009
First Received: December 3, 2007   Last Updated: September 9, 2009   History of Changes
Sponsor: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00566969
  Purpose

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.

Currently this study's recruitment stopped as of July 1, 2008 with 17 completers.


Condition Intervention
To be Drug Free. Decrease the Amount of Cocaine Used While Participating in This Study.
Drug: sugar pill
Drug: carvedilol
Drug: Methadone

Study Type: Interventional
Study Design: Health Services Research, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment
Official Title: Cocaine Withdrawal and Pharmacotherapy Response

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: September 2007
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sugar Pill: Placebo Comparator Drug: sugar pill
randomly given 25mg or 50mg of a sugar pill or the active comparator
drug: Active Comparator Drug: carvedilol
randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
Methadone Drug: Methadone
Maintenance

Detailed Description:

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 is active and ongoing. Recruitment is ongoing.9.9.09

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566969

Contacts
Contact: Stacy Minnix, Bsw 937-4805 stacy.minnix@yale.edu
Contact: Lance Barnes 203-937-4823 lance.barnes@yale.edu

Locations
United States, Connecticut
Veterans Hospital Recruiting
West Haven, Connecticut, United States, 06516
Contact: Mehmet Sofuoglu, M.D., Ph.D.     203-937-4809     mehmet.sofuoglu@yale.edu    
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University ( Mehmet Sofuoglu M.D., Ph.D. )
Study ID Numbers: NIDA R01DA014537, R01 DA014537, DPMCDA
Study First Received: December 3, 2007
Last Updated: September 9, 2009
ClinicalTrials.gov Identifier: NCT00566969     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Cocaine Addictions

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Respiratory System Agents
Vasodilator Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Adrenergic beta-Antagonists
Analgesics
Cocaine
Analgesics, Opioid
Carvedilol
Central Nervous System Depressants
Narcotics
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Anesthetics, Local
Methadone
Adrenergic Antagonists
Dopamine Agents
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009