Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218426
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2005-09-16
Brief Title:
Addiction Treatment in Russia Oral vs Naltrexone Implant
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Addiction Treatment in Russia Oral and Depot Naltrexone
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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-blinddouble-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 managementadherence 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
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-blinddouble-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 managementadherence 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA017317 | NIH | None | None |
| R01-17317-1 | None | None | None |
| DPMC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DA017317 |