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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
National Institute on Drug Abuse (NIDA) |
| Information provided by (Responsible Party): | Mehmet Sofuoglu, Yale University |
| 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.
| 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Sugar Pill |
Drug: sugar pill
randomly given 25mg or 50mg of a sugar pill or the active comparator
Other Name: sugar pill
|
| Active Comparator: drug |
Drug: carvedilol
randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
Other Name: carvedilol
|
| Methadone |
Drug: Methadone
Maintenance
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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 enrollment is continuing.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lance Barnes | 937-4823 | lance.barnes@yale.edu |
| Contact: Stacy Minnix, B.S.w. | 203-937-4808 | stacy.minnix@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: | 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 15, 2011 |
| Health Authority: | United States: Federal Government |
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drug free, Decrease the amount of cocaine used while participating in this study. |
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Substance Withdrawal Syndrome Behavior, Addictive Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Compulsive Behavior Impulsive Behavior Cocaine Carvedilol Methadone Contraceptives, Oral Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |