Addiction Treatment in Russia: Oral vs. Naltrexone Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00218426
Recruitment Status : Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : February 26, 2018
National Institute on Drug Abuse (NIDA)
St. Petersburg State Pavlov Medical University
Leningrad Addiction Treatment & Research Center, Leningrad Region, Russia
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Heroin Dependence Opioid-Related Disorders Drug: naltrexone implant Drug: Oral naltrexone Drug: placebo oral and placebo implant Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addiction Treatment in Russia: Oral and Depot Naltrexone
Actual Study Start Date : July 2006
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

Arm Intervention/treatment
Active Comparator: ON
Oral naltrexone
Drug: Oral naltrexone
oral naltrexone 50 mg/day

Experimental: DNI
naltrexone implant
Drug: naltrexone implant
The implant is 1000 mg naltrexone

Placebo Comparator: ONP
daily placebo oral naltrexone and placebo implant every 8 weeks
Drug: placebo oral and placebo implant
placebos resemble active medications

Primary Outcome Measures :
  1. Relapse to heroin addiction (measured at Months 1 and 6) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Time to dropout for treatment [ Time Frame: 6 months ]
  2. positive opioid urine test [ Time Frame: 6 months ]
  3. use of alcohol and other drugs [ Time Frame: 6 months ]
  4. psychiatric symptoms [ Time Frame: 6 months ]
  5. HIV risk (measured at Months 1, 6, 9, and 12) [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00218426

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104 6178
Russian Federation
Pavlov Medical University
St. Petersburg, Russian Federation, 197022
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
St. Petersburg State Pavlov Medical University
Leningrad Addiction Treatment & Research Center, Leningrad Region, Russia
Principal Investigator: George Woody, MD University of Pennsylvania

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Pennsylvania Identifier: NCT00218426     History of Changes
Other Study ID Numbers: NIDA-17317-1
R01DA017317 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents