Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332228
Status:
COMPLETED
Last Update Posted:
2012-10-26
First Post:
2006-05-30
Brief Title:
Behavioral Naltrexone Therapy A Novel Treatment for Heroin Dependence
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Study Behavioral Naltrexone Therapy A Novel Treatment for Heroin Dependence
Status:
COMPLETED
Status Verified Date:
2012-10
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:
The overall goal of this research project is to test the efficacy of a newly developed therapy Behavioral Naltrexone Therapy BNT to enhance the success of naltrexone maintenance and long-term abstinence for individuals with heroin dependence This study includes free detox and outpatient treatment for opioid dependence that includes medication and a behavioral intervention
Detailed Description:
The goal of this Stage II project is to test the efficacy of a new combination of behavioral therapy with oral naltrexone maintenance for the treatment of heroin addiction and to test a new long-acting depot parenteral formulation of naltrexone in initiating treatment
1 Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus compliance enhancement therapy Hypotheses
2 Injections of depot naltrexone will reduce early attrition improve initial stabilization on oral naltrexone and improve long-term outcome particularly when combined with Behavioral Naltrexone Therapy
3 Patients who exhibit escalating levels of commitment language strength throughout one early session of BNT will remain in treatment longer will take more doses of naltrexone and will provide a higher percentage of opiate-free urines
4 Increased commitment language strength on the part of the SO monitor will contribute independently to the outcome of the identified patient when controlling for patient level commitment
A critical objective of this current proposal is to improve retention particularly in the initial weeks of treatment Preliminary work with a new depot formulation of naltrexone was conducted Comer et al 1999 unpublished data showing that it is well tolerated and provides therapeutic blood levels and blockade of opiate effects for up to four weeks after a single injection By removing the option of stopping naltrexone to sample heroin a common mode of relapse we hope to prevent early attrition and fully expose all patients to the behavioral regimen of BNT intended to shape strong compliance with oral naltrexone and motivation for abstinence and lifestyle change
160 heroin-dependent individuals seeking treatment will be recruited at PI STARS or referred from other sites eg private physician other detoxification programs Prospective patients will be offered hospitalization for detoxification for rapid transition to naltrexone followed by outpatient naltrexone maintenance and counseling for six months All enrolled participants will be encouraged to return for follow-up assessment visits at one three and six months beyond the completion of their participation for research purposes
Patients will be randomly assigned to either the newly developed BNT or Compliance Enhancement Therapy CET a manual-guided approach developed by Carroll and OMalley at Yale University as a control condition for psychotherapy studies with substance dependent patients Patients will also be randomly assigned to receive either active or placebo injections of depot naltrexone prior to discharge from the detoxification Therefore there will be four treatment conditions with 40 participants per condition These four conditions include 1 BNT plus two doses of depot naltrexone prior to hospital discharge 2 BNT plus two placebo injections 3 Compliance Enhancement CE simulating standard treatment with oral naltrexone plus two depot naltrexone injections and 4 CE plus two placebo injections
1 Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus compliance enhancement therapy Hypotheses
2 Injections of depot naltrexone will reduce early attrition improve initial stabilization on oral naltrexone and improve long-term outcome particularly when combined with Behavioral Naltrexone Therapy
3 Patients who exhibit escalating levels of commitment language strength throughout one early session of BNT will remain in treatment longer will take more doses of naltrexone and will provide a higher percentage of opiate-free urines
4 Increased commitment language strength on the part of the SO monitor will contribute independently to the outcome of the identified patient when controlling for patient level commitment
A critical objective of this current proposal is to improve retention particularly in the initial weeks of treatment Preliminary work with a new depot formulation of naltrexone was conducted Comer et al 1999 unpublished data showing that it is well tolerated and provides therapeutic blood levels and blockade of opiate effects for up to four weeks after a single injection By removing the option of stopping naltrexone to sample heroin a common mode of relapse we hope to prevent early attrition and fully expose all patients to the behavioral regimen of BNT intended to shape strong compliance with oral naltrexone and motivation for abstinence and lifestyle change
160 heroin-dependent individuals seeking treatment will be recruited at PI STARS or referred from other sites eg private physician other detoxification programs Prospective patients will be offered hospitalization for detoxification for rapid transition to naltrexone followed by outpatient naltrexone maintenance and counseling for six months All enrolled participants will be encouraged to return for follow-up assessment visits at one three and six months beyond the completion of their participation for research purposes
Patients will be randomly assigned to either the newly developed BNT or Compliance Enhancement Therapy CET a manual-guided approach developed by Carroll and OMalley at Yale University as a control condition for psychotherapy studies with substance dependent patients Patients will also be randomly assigned to receive either active or placebo injections of depot naltrexone prior to discharge from the detoxification Therefore there will be four treatment conditions with 40 participants per condition These four conditions include 1 BNT plus two doses of depot naltrexone prior to hospital discharge 2 BNT plus two placebo injections 3 Compliance Enhancement CE simulating standard treatment with oral naltrexone plus two depot naltrexone injections and 4 CE plus two placebo injections
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 |
|---|---|---|---|
| R01DA010746 | NIH | None | httpsreporternihgovquickSearchR01DA010746 |