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NCT02496403 · ClinicalTrials.gov registry record · NA
Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence
A NA study of Opiate Substitution Treatment, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 239
- Enrollment target
- 1
- Study location
NCT02496403 is a NA study of Opiate Substitution Treatment that has completed, run by Kaiser Permanente. The registered enrollment target is 239 participants, below the 354-participant average among 3 other Opiate Substitution Treatment trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02496403, a NA study of Opiate Substitution Treatment, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 239 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized trial of two group-based models of care for buprenorphine/naloxone (bup/nx) patients in Substance Use (SU) specialty treatment: Standard Medical Management (SMM) and Intensive Outpatient Treatment (IOT). The setting is a large outpatient SU treatment program, where a medical management model of care has not been empirically tested with bup/nx patients, and where a high prevalence of patients with co-occurring psychiatric and medical co-morbidities are treated. SSM includes brief weekly group-based visits consistent with previously studied medical models, and is drawn from primary care bup/nx research. IOT is a predominant model of care in specialty treatment, and incorporates psychosocial support, 12-step, educational and relapse-prevention based approaches. The investigators will recruit 300 adult patients inducted onto bup/nx, randomize them to either SMM or IOT, and conduct telephone follow-up interviews at 6 and 12 months. Study investigators will examine the impact of these treatment approaches on 90-day bup/nx adherence, opioid and SU abstinence, quality of life, and health care and societal costs. Further, investigators will examine whether the effect of IOT versus SMM on adherence and SU treatment outcomes is greater for those with medical or psychiatric co-morbidities. This innovative approach includes a focus on complex patients with psychiatric and medical co-morbidities in specialty care, adapting a care model previously only tested in primary care, a 12-month follow-up, no research-forced medication taper, an examination of health care and societal costs, and a combination of patient self-report and electronic medical record data. Through this approach, the proposed study will yield critically important findings on how best to treat complex prescription opioid dependent patients with an integrative behavioral services and medication treatment model in SU treatment.
Conditions Studied
Interventions
- BEHAVIORAL Standard Medical Management (SMM)
Study Locations (1)
California
- Kaiser Sacramento Chemical Dependency Recovery Program - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2015-12 |
| Est. Completion | 2019-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02496403
The ClinicalTrials.gov registry entry for NCT02496403 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 239 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 354-participant average among 3 other Opiate Substitution Treatment trials with a reported enrollment target (32% lower). The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Opiate Substitution Treatment appearing as the primary indexed condition, and to 1 intervention - of which Standard Medical Management (SMM) is the first listed.
NCT02496403 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02496403 about?
NCT02496403 is a clinical study titled "Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence". This is a randomized trial of two group-based models of care for buprenorphine/naloxone (bup/nx) patients in Substance Use (SU) specialty treatment: Standard Medical Management (SMM) and Intensive Outpatient Treatment (IOT). The setting is a large outpatient SU treatment program, where a medical man...
What is the current status of trial NCT02496403?
This trial is currently completed. It is a NA study. The enrollment target is 239 participants. The study started on 2015-12. Estimated completion is 2019-05.
What conditions does trial NCT02496403 study?
This clinical trial studies the following conditions: Opiate Substitution Treatment.
What interventions are being tested in trial NCT02496403?
The interventions under investigation include: Standard Medical Management (SMM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02496403?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02496403 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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