Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence
NCT ID: NCT02496403
Last Updated: 2019-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
239 participants
INTERVENTIONAL
2015-12-31
2019-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard Medical Management
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.
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.
Intensive Outpatient Treatment
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Cynthia Campbell, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente Division of Research
Locations
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Kaiser Sacramento Chemical Dependency Recovery Program
Sacramento, California, United States
Countries
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References
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International Symposium on Electroanalysis in Biochemical, Environmental and Industrial Sciences. Loughborough, UK, 11-14 April, 1989. Proceedings. Analyst. 1989 Dec;114(12):1517-705. doi: 10.1039/an9891401517. No abstract available.
Haddad MS, Zelenev A, Altice FL. Integrating buprenorphine maintenance therapy into federally qualified health centers: real-world substance abuse treatment outcomes. Drug Alcohol Depend. 2013 Jul 1;131(1-2):127-35. doi: 10.1016/j.drugalcdep.2012.12.008. Epub 2013 Jan 17.
Stein BD, Gordon AJ, Sorbero M, Dick AW, Schuster J, Farmer C. The impact of buprenorphine on treatment of opioid dependence in a Medicaid population: recent service utilization trends in the use of buprenorphine and methadone. Drug Alcohol Depend. 2012 Jun 1;123(1-3):72-8. doi: 10.1016/j.drugalcdep.2011.10.016. Epub 2011 Nov 16.
Soeffing JM, Martin LD, Fingerhood MI, Jasinski DR, Rastegar DA. Buprenorphine maintenance treatment in a primary care setting: outcomes at 1 year. J Subst Abuse Treat. 2009 Dec;37(4):426-30. doi: 10.1016/j.jsat.2009.05.003. Epub 2009 Jun 23.
Manchikanti L, Fellows B, Ailinani H, Pampati V. Therapeutic use, abuse, and nonmedical use of opioids: a ten-year perspective. Pain Physician. 2010 Sep-Oct;13(5):401-35.
Kenan K, Mack K, Paulozzi L. Trends in prescriptions for oxycodone and other commonly used opioids in the United States, 2000-2010. Open Med. 2012 Apr 10;6(2):e41-7. Print 2012.
Graybill JR. Histoplasmosis and AIDS. J Infect Dis. 1988 Sep;158(3):623-6. doi: 10.1093/infdis/158.3.623. No abstract available.
Presl J. [Bioactive and immunoreactive gonadotropins]. Cesk Gynekol. 1986 Jun;51(5):354-8. No abstract available. Czech.
Sitges-Serra A, Alonso M, de Lecea C, Gores PF, Sutherland DE. Pancreatitis and hyperparathyroidism. Br J Surg. 1988 Feb;75(2):158-60. doi: 10.1002/bjs.1800750224.
Heinen E, Braun M, Louis E, Cormann N, Tsunoda R, Kinet-Denoel C, Lesage F, Simar LJ. Interactions between follicular dendritic cells and lymphoid cells. Adv Exp Med Biol. 1988;237:181-4. doi: 10.1007/978-1-4684-5535-9_26. No abstract available.
Kitagawa T, Pitot HC. Immunohistochemical demonstration of serine dehydratase in rat liver. Am J Pathol. 1975 Feb;78(2):309-18.
Kuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007 Jan 17;297(3):249-51. doi: 10.1001/jama.297.3.249. No abstract available.
Coben JH, Davis SM, Furbee PM, Sikora RD, Tillotson RD, Bossarte RM. Hospitalizations for poisoning by prescription opioids, sedatives, and tranquilizers. Am J Prev Med. 2010 May;38(5):517-24. doi: 10.1016/j.amepre.2010.01.022.
Oakey RE. Steroid sulphatase deficiency. J Endocrinol. 1987 Mar;112(3):341-3. doi: 10.1677/joe.0.1120341. No abstract available.
Related Links
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Centers for Disease Control and Prevention. Vital signs: Overdoses of prescription opioid pain relievers --- United States, 1999--2008. MMWR. 2011;60(43):1487-1492.
Other Identifiers
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CN-13-1592-H
Identifier Type: -
Identifier Source: org_study_id
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