Tracking Information
Start Date ICMJE | February 2006 |
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Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: February 19, 2008) | Heroin relapse [ Time Frame: duration of study ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: September 16, 2005) | Drug relapse; measured at Month 6 |
Change History | Complete list of historical versions of study NCT00142948 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: February 19, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: January 19, 2006) |
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Descriptive Information
Brief Title ICMJE | Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts |
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Official Title ICMJE | Heroin Addiction Treatment: Naltrexone and Adrenergic Agents |
Brief Summary | Naltrexone is a medication that is currently used to treat drug and alcohol addiction. Guanfacine is a medication that is currently used to manage the withdrawal symptoms in individuals undergoing opioid detoxification. A combination of these two medications may be beneficial in reducing heroin use in individuals addicted to heroin. This study will evaluate the effectiveness of naltrexone and guanfacine, alone and in combination, at reducing heroin use in heroin addicts. |
Detailed Description | Heroin addiction is a serious health problem with no available medical treatment for preventing relapse. Naltrexone is a medication that is currently used to treat substance addiction. It acts by blocking the "high" feeling produced by drugs and alcohol. Guanfacine, an antihypertensive medication, is currently used to manage the withdrawal symptoms in individuals undergoing opioid detoxification. While each of these medications is useful in the treatment of heroin addiction, a combination of the two drugs may be more effective than either medication alone. The purpose of this study is to compare the effectiveness of naltrexone, guanfacine, and a combination of naltrexone and guanfacine at reducing drug relapse in heroin addicts. This study will enroll individuals addicted to heroin who have completed a prior detoxification program at one of two addiction treatment hospitals in St. Petersburg, Russian Federation. Upon completing the detoxification program, participants will be required to stay overnight at the clinic for a 3- to 4-week inpatient stabilization period. Once stabilized, participants will begin the 6-month treatment phase of the study. During this phase, they will be randomly assigned to receive one of the following drug combinations on a daily basis: 50 mg of naltrexone and guanfacine placebo; 1.0 mg of guanfacine and naltrexone placebo; 50 mg of naltrexone and 1.0 mg of guanfacine; or naltrexone placebo and guanfacine placebo. All participants will have a designated family member who will be responsible for supervising medication compliance. Study visits will occur twice a week. Participants will receive clinical management and medication compliance counseling at each visit; family members will also take part in the counseling sessions. Outcome measurements will include drug relapse, medication adherence, withdrawal symptoms, HIV risk factors, and psychiatric symptoms. Follow-up evaluations will occur 3 and 6 months following the end of treatment. |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Condition ICMJE | Heroin Dependence |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 280 |
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Estimated Completion Date | July 2010 |
Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 40 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00142948 | ||||
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Responsible Party | Thomas Kosten, MD, Baylor College of Medicine | ||||
Study ID Numbers ICMJE | NIDA-18863, R01-DA018863, DPMC | ||||
Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
Collaborators ICMJE | US World Pharmacy | ||||
Investigators ICMJE |
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Information Provided By | National Institute on Drug Abuse (NIDA) |