search
Back to results

Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

Primary Purpose

Opiate Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interim
Comprehensive
Restored
Sponsored by
Friends Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring Heroin dependence, Interim Methadone Treatment, Counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult
  • meets criteria for methadone maintenance
  • unable to gain admission to methadone program within 14 days

Exclusion Criteria:

  • pregnant
  • acute medical or psychiatric illness

Sites / Locations

  • Friends Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Interim

Comprehensive

Restored

Arm Description

Methadone maintenance for up to 4 months with emergency counseling only for individuals on program waiting lists.

Methadone Treatment provided with counseling as usual.

Methadone Treatment with counseling provided by a clinician with a lower caseload than counseling as usual.

Outcomes

Primary Outcome Measures

Opioid positive drug tests

Secondary Outcome Measures

HIV risk behavior
Treatment Retention
Cost-benefit
Cocaine positive tests

Full Information

First Posted
July 2, 2008
Last Updated
January 8, 2015
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00712036
Brief Title
Entry Into Comprehensive Methadone Treatment Via Interim Maintenance
Official Title
Entry Into Comprehensive Methadone Treatment Via Interim Maintenance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine whether one of three levels of counseling intensity will be associated with better treatment outcomes when combined with methadone maintenance treatment for heroin-addicted adults drawn from a methadone treatment program waiting list.
Detailed Description
Waiting lists for methadone treatment programs persist, and new and more effective approaches for expanding treatment access and improving outcomes for heroin dependent individuals are needed. Recently completed research demonstrated that so-called "Interim Methadone Maintenance" (i.e., methadone with crisis counseling only, for individuals on waiting lists) was associated with greater entry into methadone treatment, less self-reported heroin and cocaine use, lower rates of opioid-positive drug tests, and lower rates of self-reported crime. The present study will build on this work by comparing three levels of counseling provided with methadone treatment: 1)"Interim" Methadone Treatment; 2) "Comprehensive" Methadone Treatment (which is the name for the usual amount of counseling provided, i.e., about once per week) and; 3)"Restored" Methadone Treatment in which the counselors will have a lower case load and will be able to provide more attention to their patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
Heroin dependence, Interim Methadone Treatment, Counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interim
Arm Type
Active Comparator
Arm Description
Methadone maintenance for up to 4 months with emergency counseling only for individuals on program waiting lists.
Arm Title
Comprehensive
Arm Type
Active Comparator
Arm Description
Methadone Treatment provided with counseling as usual.
Arm Title
Restored
Arm Type
Active Comparator
Arm Description
Methadone Treatment with counseling provided by a clinician with a lower caseload than counseling as usual.
Intervention Type
Behavioral
Intervention Name(s)
Interim
Intervention Description
Methadone maintenance with emergency counseling only for up to 4 months
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive
Intervention Description
Methadone treatment with counseling as usual
Intervention Type
Behavioral
Intervention Name(s)
Restored
Intervention Description
Methadone maintenance with counseling provided by a clinician with a lower than usual caseload
Primary Outcome Measure Information:
Title
Opioid positive drug tests
Time Frame
4 and 12 months post-baseline
Secondary Outcome Measure Information:
Title
HIV risk behavior
Time Frame
4 and 12 months post-baseline
Title
Treatment Retention
Time Frame
4 and 12 months post-baselin
Title
Cost-benefit
Time Frame
12 months post-baseline
Title
Cocaine positive tests
Time Frame
4 and 12 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult meets criteria for methadone maintenance unable to gain admission to methadone program within 14 days Exclusion Criteria: pregnant acute medical or psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Schwartz, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16793221
Citation
Schwartz RP, Jaffe JH, Highfield DA, Callaman JM, O'Grady KE. A randomized controlled trial of interim methadone maintenance: 10-Month follow-up. Drug Alcohol Depend. 2007 Jan 5;86(1):30-6. doi: 10.1016/j.drugalcdep.2006.04.017. Epub 2006 Jun 21.
Results Reference
background
PubMed Identifier
16389204
Citation
Schwartz RP, Highfield DA, Jaffe JH, Brady JV, Butler CB, Rouse CO, Callaman JM, O'Grady KE, Battjes RJ. A randomized controlled trial of interim methadone maintenance. Arch Gen Psychiatry. 2006 Jan;63(1):102-9. doi: 10.1001/archpsyc.63.1.102.
Results Reference
background
PubMed Identifier
17784892
Citation
Highfield DA, Schwartz RP, Jaffe JH, O'Grady KE. Intravenous and intranasal heroin-dependent treatment-seekers: characteristics and treatment outcome. Addiction. 2007 Nov;102(11):1816-23. doi: 10.1111/j.1360-0443.2007.01998.x. Epub 2007 Sep 3.
Results Reference
background
PubMed Identifier
21353445
Citation
Schwartz RP, Kelly SM, O'Grady KE, Gandhi D, Jaffe JH. Interim methadone treatment compared to standard methadone treatment: 4-month findings. J Subst Abuse Treat. 2011 Jul;41(1):21-9. doi: 10.1016/j.jsat.2011.01.008. Epub 2011 Feb 24.
Results Reference
background
PubMed Identifier
24239030
Citation
Schwartz RP, Alexandre PK, Kelly SM, O'Grady KE, Gryczynski J, Jaffe JH. Interim versus standard methadone treatment: a benefit-cost analysis. J Subst Abuse Treat. 2014 Mar;46(3):306-14. doi: 10.1016/j.jsat.2013.10.003. Epub 2013 Oct 14.
Results Reference
result
PubMed Identifier
22029398
Citation
Schwartz RP, Kelly SM, O'Grady KE, Gandhi D, Jaffe JH. Randomized trial of standard methadone treatment compared to initiating methadone without counseling: 12-month findings. Addiction. 2012 May;107(5):943-52. doi: 10.1111/j.1360-0443.2011.03700.x. Epub 2012 Feb 11.
Results Reference
result
PubMed Identifier
22134175
Citation
Kelly SM, Schwartz RP, O'grady KE, Gandhi D, Jaffe JH. Impact of methadone with versus without drug abuse counseling on HIV risk: 4- and 12-month findings from a clinical trial. J Addict Med. 2012 Jun;6(2):145-52. doi: 10.1097/ADM.0b013e31823ae556.
Results Reference
result

Learn more about this trial

Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

We'll reach out to this number within 24 hrs