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| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
· current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco);
Contacts and Locations| Contact: Stacy Minnix, Bsw | 937-4805 | stacy.minnix@yale.edu |
| Contact: Lance Barnes | 203-937-4823 | lance.barnes@yale.edu |
| 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. | |
| Principal Investigator: | Mehmet Sofuoglu, M.D., Ph.D. | Yale University |
More Information
| 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 |
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Cocaine Addictions |
|
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 |