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Addiction Treatment in Russia: Oral vs. Naltrexone Implant

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heroin Dependence; Opioid-Related Disorders

Intervention: naltrexone implant (Drug); Oral naltrexone (Drug); placebo oral and placebo implant (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
George Woody, MD, Principal Investigator, Affiliation: University of Pennsylvania

Summary

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.

Clinical Details

Official title: Addiction Treatment in Russia: Oral and Depot Naltrexone

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Relapse to heroin addiction (measured at Months 1 and 6)

Secondary outcome:

Time to dropout for treatment

positive opioid urine test

use of alcohol and other drugs

psychiatric symptoms

HIV risk (measured at Months 1, 6, 9, and 12)

Detailed description: 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. An interim analysis was done on the first 190 patients who completed the study and found a significant effect on relapse prevention of the naltrexone implant as compared to oral and placebo naltrexone, with corresponding risk reduction in HIV risk injection practices. There was a slight trend for oral naltrexone vs. placebo for relapse prevention, but unlike our earlier studies, it was not significant. We think that the apparent loss of efficacy for oral naltrexone is because the patients are now older and it is more difficult to enlist their mothers and other close relatives in supervising adherence. These preliminary findings were presented at the 2009 CPDD meeting in Reno, NV.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Current opioid dependence

- Recently completed opioid detoxification

Exclusion Criteria:

- Serious medical or psychiatric condition requiring immediate hospitalization or that

would make participation in the study hazardous

- Planning to leave the study area within the 12 months following study entry

- Imminent incarceration

- Pregnancy

Locations and Contacts

Pavlov Medical University, St. Petersburg 197022, Russian Federation

University of Pennsylvania, Philadelphia, Pennsylvania 19104 6178, United States

Additional Information

Starting date: July 2006
Last updated: July 3, 2012

Page last updated: August 23, 2015

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