Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

NCT ID: NCT00712036

Last Updated: 2015-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-01-31

Brief Summary

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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

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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.

Conditions

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Opiate Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interim

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

Group Type ACTIVE_COMPARATOR

Interim

Intervention Type BEHAVIORAL

Methadone maintenance with emergency counseling only for up to 4 months

Comprehensive

Methadone Treatment provided with counseling as usual.

Group Type ACTIVE_COMPARATOR

Comprehensive

Intervention Type BEHAVIORAL

Methadone treatment with counseling as usual

Restored

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

Group Type ACTIVE_COMPARATOR

Restored

Intervention Type BEHAVIORAL

Methadone maintenance with counseling provided by a clinician with a lower than usual caseload

Interventions

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Interim

Methadone maintenance with emergency counseling only for up to 4 months

Intervention Type BEHAVIORAL

Comprehensive

Methadone treatment with counseling as usual

Intervention Type BEHAVIORAL

Restored

Methadone maintenance with counseling provided by a clinician with a lower than usual caseload

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Friends Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert P Schwartz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

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Friends Research Institute

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16793221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16389204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17784892 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21353445 (View on PubMed)

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.

Reference Type RESULT
PMID: 24239030 (View on PubMed)

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.

Reference Type RESULT
PMID: 22029398 (View on PubMed)

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.

Reference Type RESULT
PMID: 22134175 (View on PubMed)

Other Identifiers

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R01DA013636

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DA R01 13636

Identifier Type: -

Identifier Source: org_study_id

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