Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

• Sponsor: Friends Research Institute, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT00712036
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 230
• Location: 1
• Arms: 3
• Duration (Months): 31
• Patients Per Site Per Month: 7.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence	Behavioral: Interim; Behavioral: Comprehensive; Behavioral: Restored	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Entry Into Comprehensive Methadone Treatment Via Interim Maintenance
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Interim Methadone maintenance for up to 4 months with emergency counseling only for individuals on program waiting lists.	Behavioral: Interim; Methadone maintenance with emergency counseling only for up to 4 months
Active Comparator: Comprehensive Methadone Treatment provided with counseling as usual.	Behavioral: Comprehensive; Methadone treatment with counseling as usual
Active Comparator: Restored Methadone Treatment with counseling provided by a clinician with a lower caseload than counseling as usual.	Behavioral: Restored; Methadone maintenance with counseling provided by a clinician with a lower than usual caseload

Outcome Measures

Primary Outcome Measures

1. Opioid positive drug tests [4 and 12 months post-baseline]

Secondary Outcome Measures

1. HIV risk behavior [4 and 12 months post-baseline]

2. Treatment Retention [4 and 12 months post-baselin]

3. Cost-benefit [12 months post-baseline]

4. Cocaine positive tests [4 and 12 months post-baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Friends Research Institute	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• Friends Research Institute, Inc.
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Robert P Schwartz, M.D., Friends Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Epub 2007 Sep 3.
• 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.
• 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. Epub 2006 Jun 21.
• 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.

• Responsible Party: Friends Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT00712036
• Other Study ID Numbers: DA R01 13636; R01DA013636
• First Posted: Jul 9, 2008
• Last Update Posted: Jan 9, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Friends Research Institute, Inc.: Heroin dependence; Interim Methadone Treatment; Counseling
• Additional relevant MeSH terms: Opioid-Related Disorders

Study Results

No Results Posted as of Jan 9, 2015