Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence

NCT02496403 | Completed

• 2 other identifiers: CN-13-1592-HR01DA036603
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Substitution Treatment

Keywords

buprenorphine-naloxone combination; Suboxone; Buprenorphine; Substance Use; Behavioral intervention; Opioid partial agonist; medication assisted therapy; opioid addiction

Outcome Measures

Primary Outcomes (5)

• Adherence to buprenorphine/naloxone using MPR

  Buprenorphine/naloxone adherence will be measured using KPNC's pharmacy database. Adherence will be based on prescription refills and calculated using Medication Possession Ratio methods, similar to other published KPNC studies which have measured adherence as a key outcome variable. Adherence will be defined as the patient having medication available on 80% or more of the 90 day period-that is, an MPR of .8 or higher.

  90-day

• Abstinence using ASI

  We use composite measures from the Addiction Severity (ASI) index to examine 30 day abstinence outcomes for opioids and other substances (marijuana, cocaine, methamphetamine and other stimulants, hallucinogens, barbiturates, tranquilizers, inhalants, hallucinogens).

  6 months

• Health care utilization costs using ICER

  Substance use treatment utilization data (number of visits, number of days in treatment), as well as general health care utilization data (inpatient, outpatient, and ER) will be collected using the electronic medical record. In addition, health care utilization outside Kaiser will be assessed and used to create composite measure of health care utilization costs. The incremental cost-effectiveness ratio (ICER) will be calculated for each additional unit of outcome as the ratio of difference in costs between the two arms divided by the difference in outcome.

  12 months

• Adherence to buprenorphine/naloxone using drug testing

  Urine tests will be performed weekly during treatment. If 80% of test results within the 90-day period are positive during the 90 day period, we will consider the patient to be adherent to treatment.

  90-day

• Abstinence using ASI

  We use composite measures from the Addiction Severity (ASI) index to examine 30 day abstinence outcomes for opioids and other substances (marijuana, cocaine, methamphetamine and other stimulants, hallucinogens, barbiturates, tranquilizers, inhalants, hallucinogens).

  12 months

Secondary Outcomes (6)

• Chronic Pain using the pain Interference scale

  6 months

• Quality of Life using PROMIS Global Health scale

  6 months

• Mental health using PHQ-9

  6 months

• Chronic Pain using the pain Interference scale

  12 months

• Mental health using PHQ-9

  12 months

Study Arms (2)

Standard Medical Management

EXPERIMENTAL

Standard Medical Management (SMM) is a relatively brief (1.5 hour per week for 9 weeks), medically-focused behavioral intervention for opioid dependence. The experimental arm does not involve an investigational drug, device, or biologic.

Behavioral: Standard Medical Management (SMM)

Intensive Outpatient Treatment

NO INTERVENTION

The Intensive Outpatient Treatment (IOT) arm is considered usual care and is a predominant model of care in specialty treatment. It incorporates psychosocial support, education, and relapse-prevention approaches and requires attendance at 12-step program. It is a group-based treatment, with individual counseling available as needed. During the initial, 3-week phase, treatment consists of 4-6 hours a day, 7 days a week. In weeks four through 9, treatment consists of 1.5 hours, four days each week. After 9 weeks, patients attend one-hour weekly group meetings for one year. Services include supportive therapy, psycho-education, relapse prevention, and family-oriented therapy. The program emphasis is on abstinence and is similar to many public and private intensive outpatient programs.

Interventions

Standard Medical Management (SMM) BEHAVIORAL

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.

Standard Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Kaiser Sacramento Chemical Dependency Recovery Program

Sacramento, California, 95821, United States

Location

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Related Links

• Centers for Disease Control and Prevention. Vital signs: Overdoses of prescription opioid pain relievers --- United States, 1999--2008. MMWR. 2011;60(43):1487-1492.

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• Cynthia Campbell, PhD

  Kaiser Permanente Division of Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 14, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

US (1)