Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/10/2018 |
| Start Date: | December 2015 |
| End Date: | May 2019 |
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.
(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.
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.
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.
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
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