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Opiate DependenceNCT00712036

Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

A study testing Interim, Comprehensive and Restored in people with Opiate Dependence, run by Friends Research Institute, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opiate Dependence
What is being tested?
Interim, Comprehensive and Restored
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
1 siteUnited States
Study dates
Jun 2008to Jan 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • pregnant
  • acute medical or psychiatric illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Friends Research Institute

    Baltimore, Maryland, 21201

Other trials in United States

About this study

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.

Read the 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.

Being tested
Interim, Comprehensive, Restored
Keywords
Heroin dependence, Interim Methadone Treatment, Counseling
Medical subject headings
Opioid-Related Disorders, Heroin Dependence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterimBehavioural

    Methadone maintenance with emergency counseling only for up to 4 months

  • ComprehensiveBehavioural

    Methadone treatment with counseling as usual

  • RestoredBehavioural

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

Study groups in NCT00712036
Study groupRoleWhat they receive
InterimActive comparatorMethadone maintenance for up to 4 months with emergency counseling only for individuals on program waiting lists.
Receives: Behavioral: Interim
ComprehensiveActive comparatorMethadone Treatment provided with counseling as usual.
Receives: Behavioral: Comprehensive
RestoredActive comparatorMethadone Treatment with counseling provided by a clinician with a lower caseload than counseling as usual.
Receives: Behavioral: Restored

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid positive drug tests

    Measured: 4 and 12 months post-baseline

Secondary outcomes (4)

  1. HIV risk behavior

    Measured: 4 and 12 months post-baseline

  2. Treatment Retention

    Measured: 4 and 12 months post-baselin

  3. Cost-benefit

    Measured: 12 months post-baseline

  4. Cocaine positive tests

    Measured: 4 and 12 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00712036
Sponsor's protocol ID
DA R01 13636
Other IDs
R01DA013636
Status last verified
Jan 2015
First submitted
2 Jul 2008
Last updated
9 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16793221

  • 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.

    PubMed 16389204

  • 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.

    PubMed 17784892

  • 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.

    PubMed 21353445

  • 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.

    PubMed 24239030

  • 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.

    PubMed 22029398

  • 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.

    PubMed 22134175

Questions about this trial

What is this clinical trial studying?

A study testing Interim, Comprehensive and Restored in people with Opiate Dependence, run by Friends Research Institute, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid positive drug tests (time frame: 4 and 12 months post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00712036, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.

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