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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.
 
ClinicalTrials.gov Identifier: NCT00218426
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : February 27, 2019
Last Update Posted : March 18, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
St. Petersburg State Pavlov Medical University
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: oral placebo naltrexone Drug: 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 selective serotonin reuptake inhibitor (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, 306 patients will be randomly assigned to a 6-month treatment in one of three groups of 102 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.

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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 : June 2009
Actual Study Completion Date : November 4, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

Arm Intervention/treatment
Active Comparator: ONP + DNI
Oral naltrexone placebo (ONP) + Depot Naltrexone Implant (DNI) 1000 mg
Drug: naltrexone implant
naltrexone implant is 1000 mg naltrexone
Other Name: DNI

Drug: oral placebo naltrexone
oral placebo naltrexone resembles active medication
Other Name: ONP

Active Comparator: ON + DNIP
Oral naltrexone (ON) 50 mg + Depot Naltrexone placebo Implant (DNIP)
Drug: oral naltrexone
oral naltrexone 50 mg/day
Other Name: ON

Drug: placebo implant
placebo implant resembles active medication
Other Name: DNIP

Placebo Comparator: ONP + DNIP
Oral placebo naltrexone + placebo naltrexone implant
Drug: oral placebo naltrexone
oral placebo naltrexone resembles active medication
Other Name: ONP

Drug: placebo implant
placebo implant resembles active medication
Other Name: DNIP




Primary Outcome Measures :
  1. Retention Without Relapse to Heroin Addiction (Measured at Month 6) [ Time Frame: 6 months ]
    Survival analysis (Kaplan-Meier survival functions with log-rank Cox-Mantel criteria for group comparison was used to determine the primary outcome of retention, defined as not missing 2 consecutive counseling sessions and not having a relapse. Because this outcome combined patients who failed to keep appointments with those who kept appointments but relapsed, the proportion of non-survivors attributable to proven relapse.


Secondary Outcome Measures :
  1. Number of Subjects Who Dropped Out of Treatment [ Time Frame: 6 months ]
    Kaplan-Meier survival curves for the event of subjects who dropped out of treatment

  2. Positive Opioid Urine Test [ Time Frame: 6 months ]
    missed urine tests were imputed to be positive for opiates

  3. Use of Alcohol [ Time Frame: 6 months ]
    use of alcohol grams per day

  4. Composite Score of Psychiatric Problems [ Time Frame: 6 months ]
    composite score is a decimal score; with 0 = no problems, 1 = the most problems based on the Addiction Severity Index composite score of 11 indexed questions.

  5. HIV Risk (Baseline) [ Time Frame: baseline ]
    The Risk Assessment Behavior (RAB), is an HIV risk Scale. The Total Score is scored by adding the values that correspond to the responses selected by the subject for the items asked. This highest total score is 40 (highest risk), and the lowest score = 0 (no risk). This assessment has 2 Subsections: 1) Drug Risk = 8 questions (lowest Drug Risk score = 0 (no risk), and highest drug risk score = 22 =(greatest risk), 2) 10 Sex Risk questions: scores are 0 = no risk, and 18 = highest risk). Total RAB Score = Drug Risk Total + Sex Risk Total (0 = no risk, 40 = highest). See: Risk Assessment Battery (RAB) Scoring System, https://www.med.upenn.edu/hiv/assets/user-content/.../RABScoringv2.112.21.95.doc

  6. Global Assessment Form (GAF) [ Time Frame: baseline ]
    Assessment of overall psychiatric function comprises Axis V in the DSM-IV (DSM-IV, 1994). GAF scores range from 0 to 100. A reasonably well-functioning person will score above 70; serious impairment is below 50.

  7. Amphetamine Drug Use [ Time Frame: baseline ]
    Number of subjects who used Amphetamine in the past 90 days at baseline as measured by the TimeLine Follow-back Form (TLFB) . The TLFB is an instrument that assesses substance use over a specified period of time (Sobel & Sobel, 1992).

  8. Cocaine Drug Use [ Time Frame: baseline ]
    Number of subjects with cocaine drug use in the past 90 days at baseline as measured by the TimeLine Follow-back Form (TLFB) . The TLFB is an instrument that assesses substance use over a specified period of time (Sobel & Sobel, 1992).

  9. Marijuana Drug Use [ Time Frame: baseline ]
    Number of subjects with Marijuana use in the past 90 days at baseline as measured by the TimeLine Follow-back Form (TLFB) . The TLFB is an instrument that assesses substance use over a specified period of time (Sobel & Sobel, 1992).

  10. Benzodiazepine Drug Use [ Time Frame: baseline ]
    Number of subjects with benzodiazepine drug use in the past 90 days at baseline as measured by the TimeLine Follow-back Form (TLFB) . The TLFB is an instrument that assesses substance use over a specified period of time (Sobel & Sobel, 1992).



Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT00218426


Locations
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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
Investigators
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Principal Investigator: George Woody, MD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00218426    
Other Study ID Numbers: NIDA-17317-1
R01DA017317 ( U.S. NIH Grant/Contract )
R01-17317-1
DPMC
First Posted: September 22, 2005    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: March 18, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents