Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Heroin Addiction Treatment: Naltrexone and Adrenergic Agents|
- Heroin relapse [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
- HIV risk factors [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Psychiatric symptoms (measured at Month 6, and the 3- and 6-month follow-up evaluations) [ Time Frame: months 6 and the 3- and 6-month follow-up evaluations ] [ Designated as safety issue: No ]
- Adherence to medication [ Time Frame: duration of study ] [ Designated as safety issue: No ]
- Heroin withdrawal symptoms [ Time Frame: Month 6, and 3- and 6-month followup ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Naltrexone Oral 50 mgs daily
Placebo Comparator: Placebo
1 to 1 comparison of Naltrexone to placebo
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 of 7-14 days, participants will have a period of inpatient rehabilitation. During this 3- to 4-week inpatient stabilization period, patients will be screened for study participation. 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 monthly. 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.
|Saint Petersburg Pavlov State Medical University|
|Saint Petersburg, Russian Federation|
|Principal Investigator:||Thomas R. Kosten, MD||Baylor College of Medicine|