Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence

Completed · Not applicable

Conditions studied: Opiate Substitution Treatment

In brief

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.

Key facts

Study ID

NCT02496403

Run by

Kaiser Permanente

People needed

239

Starts

2015-12-01

Expected to finish

2019-05-01

Last updated by the study team

2019-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• inducted for buprenorphine/naloxone treatment at the Sacramento CDRP
• diagnosis of opioid dependence
• English speaking
• Willing and able to be randomized to treatment arm
• Exclusionary criteria:
• dementia
• mental retardation
• actively psychotic or suicidal
• medically unstable
• using opioids
• pregnant women
• inducted on bup/nx for chronic pain
• inducted on bup/nx for detoxification purposes only
• enrolled in DDIOP, residential treatment or day treatment

Where it is running

• Kaiser Sacramento Chemical Dependency Recovery Program — Sacramento, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.