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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218426 |
Heroin addiction is a growing problem in Russia; individuals who enter heroin addiction treatment often relapse. Therefore, effective heroin addiction treatments are necessary to prevent relapse. The purpose of this study is to compare oral naltrexone with a naltrexone implant that provides opioid blockade for two months in preventing relapse to heroin addiction in St. Petersburg, Russia.
Condition | Intervention | Phase |
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Heroin Dependence Opioid-Related Disorders |
Drug: naltrexone implant Drug: Oral naltrexone Drug: placebo oral and placebo implant |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Addiction Treatment in Russia: Oral and Depot Naltrexone |
Estimated Enrollment: | 300 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ON: Active Comparator
Oral naltrexone
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Drug: Oral naltrexone
oral naltrexone 50 mg/day
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DNI: Experimental
naltrexone implant
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Drug: naltrexone implant
The implant is 1000 mg naltrexone
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ONP: Placebo Comparator
daily placebo oral naltrexone and placebo implant every 8 weeks
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Drug: placebo oral and placebo implant
placebos resemble active medications
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The usual treatment of heroin addiction in Russia involves detoxification and 2-4 weeks of rehabilitation with referral to outpatient follow-up. Though most patients complete inpatient treatment, few keep follow-up appointments and relapse rates are high. More effective therapies are needed, especially in view of the epidemic of heroin addiction that has resulted in the spread of HIV and other infectious diseases. A recently-completed study of 52 patients randomized to oral naltrexone (ON) or oral naltrexone placebo (ONP) has shown efficacy in preventing relapse and reducing HIV risk but dropout was a problem with only 44% of ON patients proven to have not relapsed by 6 months (as compared to 16% of ONP patients). A larger study of 280 patients randomized to ON or ONP replicated these results and found some indication that adding an SSRI to naltrexone may improve its efficacy in women, probably because they tend to have higher levels of psychiatric symptoms than men.
We think that retention and outcome can be improved by using a longer acting naltrexone preparation, and in this study we propose to compare ON with a depot naltrexone implant (DNI) that is manufactured and approved for use in Russia, and provides opioid blockade for 8-10 weeks. We will use a placebo-controlled, double-blind/double-dummy design since a placebo-controlled trial is required by the Russian equivalent of our FDA as a condition for testing a pharmacotherapy. Participants will be male and female heroin addicts who have been detoxified in addiction treatment hospitals or outpatient settings in St. Petersburg and have a family member willing and able to supervise medication adherence and facilitate follow-up. After giving informed consent and confirming the absence of physiologic dependence, 300 patients will be randomly assigned to a 6-month treatment in one of three groups of 100 each: oral naltrexone (ON) + depot naltrexone implant placebo (DNIP); oral naltrexone placebo (ONP) + depot naltrexone implant (DNI); or ONP + DNIP. All patients will receive biweekly clinical management/adherence enhancement counseling. Assessments will be done at baseline, at each biweekly appointment during the 6-months of medication treatment, and at 3 and 6 months following the end of study medication. Primary outcome will be the relapse free proportion at months 1-6; secondary outcomes will be time to dropout, opioid positive urines, HIV risk, use of alcohol and other drugs, psychiatric symptoms, and other measures of overall adjustment. We hypothesize that outcomes will be better with DNI than ON, and that each will be more effective than placebo.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pennsylvania | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19104 6178 | |
Contact: George Woody, MD 215-399-0980 ext 112 woody@tresearch.org | |
Russian Federation | |
Pavlov Medical University | Recruiting |
St. Petersburg, Russian Federation, 197022 | |
Contact: Evgeny Krupitsky, MD, PhD 203-932-5711 ext 7438 kru@ek3506.spb.edu |
Principal Investigator: | George Woody, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Office of Research Services ) |
Study ID Numbers: | NIDA-17317-1, R01-17317-1, DPMC |
Study First Received: | September 16, 2005 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00218426 |
Health Authority: | United States: Federal Government |
Behavior, Addictive Mental Disorders Heroin Dependence Naltrexone |
Substance-Related Disorders Disorders of Environmental Origin Opioid-Related Disorders |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Narcotic Antagonists |
Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |