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
  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.


Condition Intervention
Cocaine Addictions
Drug: sugar pill
Drug: carvedilol
Drug: Methadone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Cocaine Withdrawal and Pharmacotherapy Response

Resource links provided by NLM:


Further study details as provided by Yale University:

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 ]

Enrollment: 77
Study Start Date: September 2007
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
To be compared to active drug
Drug: sugar pill
randomly given 25mg or 50mg of a sugar pill or the active comparator
Other Name: sugar pill
Active Comparator: Carvedilol
To be compared to sugar pill
Drug: carvedilol
randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
Other Name: carvedilol
Methadone
reduce opiate use
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 has 77 completers and currently in data analysis.

  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

Locations
United States, Connecticut
Veterans Hospital
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00566969     History of Changes
Other Study ID Numbers: NIDA R01DA014537, R01DA014537, DPMC
Study First Received: December 3, 2007
Last Updated: December 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Yale University:
drug free

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Behavior, Addictive
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Contraceptives, Oral
Methadone
Carvedilol
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014