Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

NIDA-17317-1


NCT ID:

NCT00218426


Secondary ID:

R01DA017317


Study Acronym:


Brief Title:

Addiction Treatment in Russia: Oral vs. Naltrexone Implant


Official Title:

Addiction Treatment in Russia: Oral and Depot Naltrexone


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pennsylvania


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

306


Enrollment Type:

Actual


Overall Contact Information

Official Name:George Woody, MD
Principal Investigator
University of Pennsylvania

Study Dates

Start Date:July 2006
Completion Date:November 4, 2010
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:February 2019
Last Changed Date:February 28, 2019
First Received Date:September 16, 2005
First Results Date:February 1, 2019

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Benzodiazepine Drug Use
Time Frame:baseline
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Marijuana Drug Use
Time Frame:baseline
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Cocaine Drug Use
Time Frame:baseline
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Amphetamine Drug Use
Time Frame:baseline
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Global Assessment Form (GAF)
Time Frame:baseline
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:HIV Risk (Baseline)
Time Frame:baseline
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Composite Score of Psychiatric Problems
Time Frame:6 months
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Use of Alcohol
Time Frame:6 months
Safety Issues:False
Description:use of alcohol grams per day
Outcome Type:Secondary Outcome
Measure:Positive Opioid Urine Test
Time Frame:6 months
Safety Issues:False
Description:missed urine tests were imputed to be positive for opiates
Outcome Type:Secondary Outcome
Measure:Number of Subjects Who Dropped Out of Treatment
Time Frame:6 months
Safety Issues:False
Description:Kaplan-Meier survival curves for the event of subjects who dropped out of treatment
Outcome Type:Primary Outcome
Measure:Retention Without Relapse to Heroin Addiction (Measured at Month 6)
Time Frame:6 months
Safety Issues:False
Description: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 th

Study Interventions

Intervention Type:Drug
Name:naltrexone implant
Description:naltrexone implant is 1000 mg naltrexone
Arm Name:ONP + DNI
Other Name:DNI
Intervention Type:Drug
Name:oral naltrexone
Description:oral naltrexone 50 mg/day
Arm Name:ON + DNIP
Other Name:ON
Intervention Type:Drug
Name:oral placebo naltrexone
Description:oral placebo naltrexone resembles active medication
Arm Name:ONP + DNI
Other Name:ONP
Intervention Type:Drug
Name:placebo implant
Description:placebo implant resembles active medication
Arm Name:ON + DNIP
Other Name:DNIP

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:ONP + DNIP
Description:Oral placebo naltrexone + placebo naltrexone implant
Study Arm Type:Active Comparator
Arm Name:ON + DNIP
Description:Oral naltrexone (ON) 50 mg + Depot Naltrexone placebo Implant (DNIP)
Study Arm Type:Active Comparator
Arm Name:ONP + DNI
Description:Oral naltrexone placebo (ONP) + Depot Naltrexone Implant (DNI) 1000 mg

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pennsylvania
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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