Opiate DependenceNCT01442493
Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment
A study testing Patient-Centered Methadone Treatment and Methadone Treatment as usual in people with Opiate Dependence, run by Friends Research Institute, Inc. at 2 sites in United States.
Trial summary
The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual. 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?
- Patient-Centered Methadone Treatment and Methadone Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- opiate dependence
- newly admitted to methadone treatment
Who cannot join
- pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institutes for Behavior Resources REACH
Baltimore, Maryland, 21218
University of Maryland Drug Treatment Center
Baltimore, Maryland, 21223
About this study
Official title: Reengineering Methadone Treatment: A Randomized Clinical Trial
The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.
Read the detailed description
Early drop-out and premature discharge from methadone treatment is common in the United States and may be associated with drug use and its associated problems. The purpose of this study is to evaluate the effectiveness of a novel approach to the organization methadone treatment in which the patient rules and staff roles of the clinic will be modified for study participants as compared to patients receiving standard methadone treatment.
- Conditions
- Opiate Dependence
- Being tested
- Patient-Centered Methadone Treatment, Methadone Treatment as usual
- Keywords
- Methadone Treatment, Opiate dependence, Services research
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Centered Methadone TreatmentOther
Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event.
Methadone Treatment as usualOther
Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Centered Methadone Treatment | Experimental | Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes. Receives: Other: Patient-Centered Methadone Treatment |
| Methadone Treatment as Usual | Active comparator | Methadone treatment provided as usual in the U.S. Receives: Other: Methadone Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Opiate Positive Urine Tests
Number of participants with opiate positive urine tests
Measured: 12-months post-baseline
Secondary outcomes (6)
Number of Participants With Cocaine Positive Urine Tests
Cocaine positive urine drug test
Measured: 12-months post-baseline
Drug Use HIV Risk Behavior
HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Measured: 12-months post-baseline
Criminal Behavior
Days of criminal behavior
Measured: 12-months post-baseline
Global Score on the World Health Organization Quality of Life Measure
Scale from 1 through 5. A higher score reflects a better quality of life.
Measured: 12-months post-baseline
Number of Participants Meeting DSM-IV Opiate Dependence Criteria
Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence
Measured: 12-months post-baseline
Number of Participants Meeting DSM-IV Cocaine Dependence Criteria
Number of participants meeting DSM-IV cocaine dependence criteria
Measured: 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.
- First posted28 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert P Schwartz, M.D., Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442493
- Sponsor's protocol ID
- 2R01DA015842
- Status last verified
- Dec 2017
- First submitted
- 7 Sep 2011
- Last updated
- 29 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mitchell SG, Monico LB, Lertch E, Kelly SM, Gryczynski J, Jaffe JH, O'Grady KE, Schwartz RP. Counseling Staff's Views of Patient-Centered Methadone Treatment: Changing Program Rules and Staff Roles. J Behav Health Serv Res. 2018 Jul;45(3):506-515. doi: 10.1007/s11414-018-9603-1.
PubMed 29536342
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reengineering Methadone Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01442493
- Acronym / sponsor ID
- 2R01DA015842
- Conditions
- Opiate Dependence
- Keywords
- Methadone Treatment, Opiate dependence, Services research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Posted 18 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.
Detailed description
Early drop-out and premature discharge from methadone treatment is common in the United States and may be associated with drug use and its associated problems. The purpose of this study is to evaluate the effectiveness of a novel approach to the organization methadone treatment in which the patient rules and staff roles of the clinic will be modified for study participants as compared to patients receiving standard methadone treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-Centered Methadone Treatment | Experimental | Other: Patient-Centered Methadone TreatmentPatient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes. |
| Methadone Treatment as Usual | Active comparator | Other: Methadone Treatment as usualMethadone treatment provided as usual in the U.S. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- opiate dependence
- newly admitted to methadone treatment
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Centered Methadone TreatmentUnlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event. | Other | Patient-Centered Methadone Treatment |
| Methadone Treatment as usualCounseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic. | Other | Methadone Treatment as Usual |
Primary outcome
Number of Participants With Opiate Positive Urine Tests
Time frame: 12-months post-baseline
Number of participants with opiate positive urine tests
6 secondary outcomes
Number of Participants With Cocaine Positive Urine Tests
Time frame: 12-months post-baseline
Drug Use HIV Risk Behavior
Time frame: 12-months post-baseline
Criminal Behavior
Time frame: 12-months post-baseline
Global Score on the World Health Organization Quality of Life Measure
Time frame: 12-months post-baseline
Number of Participants Meeting DSM-IV Opiate Dependence Criteria
Time frame: 12-months post-baseline
Number of Participants Meeting DSM-IV Cocaine Dependence Criteria
Time frame: 12-months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29536342Mitchell SG, Monico LB, Lertch E, Kelly SM, Gryczynski J, Jaffe JH, O'Grady KE, Schwartz RP. Counseling Staff's Views of Patient-Centered Methadone Treatment: Changing Program Rules and Staff Roles. J Behav Health Serv Res. 2018 Jul;45(3):506-515. doi: 10.1007/s11414-018-9603-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P Schwartz, M.D. principal investigator
Friends Research Institute, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Centered Methadone Treatment and Methadone Treatment as usual in people with Opiate Dependence, run by Friends Research Institute, Inc. at 2 sites 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 2 inclusion and 1 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 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 18 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Opiate Positive Urine Tests (time frame: 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 NCT01442493, which also lists 1 linked publication.
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 29 Dec 2017.