Clinical trial NCT02496403: Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence
Official title: Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Substitution Treatment
Keywords: buprenorphine-naloxone combination
Suboxone
Buprenorphine
Substance Use
Behavioral intervention
Opioid partial agonist
medication assisted therapy
opioid addiction
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-07-14
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: The study will contrast and compare the effectiveness and costs of two forms of behavioral SU treatment services for a total of 300 opioid dependent patients seeking bup/nx treatment at the Kaiser Sacramento Chemical Dependency Recovery Program (CDRP). The design is a between-groups clinical trial using blocked randomization to the two treatments (IOT and SMM) with analyses based on an intent-to-treat model.

Patients are recruited into the study and randomized after induction at the time of program intake. A full battery of background, concurrent status and diagnostic information will be collected at baseline, and repeated 6 and 12 months later to assess change in drug use, 30 day and 6-month abstinence, and quality of life at each point. The study will test for illicit drug use and presence of buprenorphine with random urinalysis throughout treatment. In addition to urinalysis, bup/nx adherence will be measured using prescription drug refills and self-report. Investigators will collect self-report of prescription opioid use and abstinence. Finally, the number and types of services received by during treatment will be available from the EMR.

Patients seeking bup/nx receive a 30-minute medical exam from a CDRP physician (e.g., for symptoms of alcohol or other drug withdrawal, hypertension, acute infections related to intravenous drug use, mental status, acute psychosis or suicidal tendencies) to assess appropriateness for bup/nx and discuss the treatment. After this initial evaluation, the induction is managed by the clinic nurse, in consultation with a clinic physician. Induction follows the standard of care, and occurs over 2-3 days. The average daily dose of bup/nx ranges from 12-24mg, but is typically 16 mg.

After induction, the patient will be scheduled for an intake interview for admission into the treatment program. Following the intake session, a research staff member will describe the study and assess eligibility criteria. For patients who agree to participate, the research associate will proceed to enroll the patient in a private room. During enrollment/baseline appointment, the research associate will obtain informed consent and administer a baseline questionnaire using a laptop computer (see below). Patients will then be randomized to either the IOT or SMM arm using a block randomization procedure which will ensure that equal numbers of patients will be assigned to each treatment arm. Patients unwilling or unable to be randomized will meet with the intake therapist and treated in the standard manner designated by the treatment program's regular intake counselors, and will not be part of the study.

At baseline, following recruitment and consent, participants will complete a computerized interview in a private place at the CDRP (with a research associate available for any computer or content questions). A full battery of background, physical and mental health and SU disorder information will be collected.

Study investigators will conduct two follow-up telephone interviews whether or not patients complete the CDRP treatment program. At the follow-up, participants will be reminded of the study and permission to conduct the interview will be obtained verbally. Interviews will be conducted at 6 and 12 months by research staff with the same baseline measures to assess treatment adherence, substance use and abstinence, and quality of life. Also, patients will be asked to present at the CDRP within 48 hours of the 6 and 12 month interviews for a urine test and additional brief questions on drug use.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Adherence to buprenorphine/naloxone using MPR
timeFrame: 90-day
measure: Abstinence using ASI
timeFrame: 6 months
measure: Health care utilization costs using ICER
timeFrame: 12 months
measure: Adherence to buprenorphine/naloxone using drug testing
timeFrame: 90-day
measure: Abstinence using ASI
timeFrame: 12 months
Secondary outcomes:
measure: Chronic Pain using the pain Interference scale
timeFrame: 6 months
measure: Quality of Life using PROMIS Global Health scale
timeFrame: 6 months
measure: Mental health using PHQ-9
timeFrame: 6 months
measure: Chronic Pain using the pain Interference scale
timeFrame: 12 months
measure: Mental health using PHQ-9
timeFrame: 12 months
measure: Quality of Life using PROMIS Global Health scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Kaiser Sacramento Chemical Dependency Recovery Program
state: California
Study officials:
affiliation: Kaiser Permanente Division of Research
name: Cynthia Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
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