Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence

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

• Opiate Substitution Treatment

Interventions

BEHAVIORAL

Standard Medical Management (SMM)

SMM is designed to provide basic advice about opioid dependence and encouragement to adhere to treatment recommendations. Sessions provide support and monitoring of medication compliance, dose, withdrawal, adverse effects, and discussion of medical complications of opioid and other drug use. Early in treatment, the focus will be on helping patients adjust to the medications (e.g., monitoring withdrawal or other adverse symptoms, tolerating discomfort, curtailing illicit drug use, and referral to self-help). As treatment progresses, the practitioner may focus more on educating the patient about the social and behavioral factors perpetuating addiction and encourage behavioral and lifestyle change to support recovery.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Kaiser Permanente

  lead OTHER

Principal Investigators

• Cynthia Campbell, PhD · Kaiser Permanente Division of Research

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2019-05-31

Completion

2019-05-31

Countries

• United States

Study Locations