Clinical Trials Logo

Clinical Trial Summary

A total of 120 male and female opioid dependent cocaine users will participate in this study. This study will be a 8-week double-blind, placebo controlled study examining the dose-dependent effects of carvedilol (up to 50 mg/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 140 mg/day). Carvedilol dose will be increased from 12.5mg/day to the target dose of either 25 or 50 mg/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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00566969
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date September 2007
Completion date January 2013

See also
  Status Clinical Trial Phase
Recruiting NCT04994821 - tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study Phase 2
Completed NCT01601743 - Exercise as a Behavioral Treatment for Cocaine Dependence N/A
Completed NCT01402492 - Cocaine Use Reduction With Buprenorphine Phase 2/Phase 3
Completed NCT01176591 - HBPL Study of the Impact of the NK1 Antagonist Aprepitant Phase 2
Completed NCT00880997 - The Efficacy of Doxazosin for Cocaine Users Phase 1
Completed NCT00585520 - Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues Phase 1
Completed NCT00368290 - Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior Phase 2
Completed NCT00322309 - Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects Phase 2
Completed NCT00385801 - Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence Phase 2
Completed NCT00167245 - Topiramate for Alcohol and Cocaine Dependence Phase 2
Completed NCT00842517 - Long Term Maintenance of Drug Abstinence Phase 1
Not yet recruiting NCT05974202 - rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder Phase 2
Completed NCT04411914 - Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid Phase 1
Active, not recruiting NCT03266939 - Rebalancing the Serotonergic System in Cocaine Dependence Phase 1
Completed NCT02563769 - Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study Phase 1
Recruiting NCT06159387 - Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts Phase 4
Terminated NCT02935101 - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants Phase 2
Completed NCT02018263 - Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans Phase 1
Withdrawn NCT01406522 - Tacrine Effects on Cocaine Self-Administration and Pharmacokinetics Phase 2
Completed NCT01573273 - Oxytocin in Cocaine Dependence N/A