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Sponsor study identifier
Secondary identifiers
NIH
interventional
239
1 country
1
Study Start
December 2015
Actual (reported)Primary Completion
May 2019
Actual (reported)Study Completion
May 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 6, 2015
Actual (reported)July 14, 2015
Actual (reported)December 2015
Actual (reported)May 2019
Actual (reported)May 2019
Actual (reported)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.
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
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kaiser Sacramento Chemical Dependency Recovery Program
Sacramento, California, 95821, United States
Miller C, Dadoo R, Kooser RG, Gorse J. Electron spin resonance studies under dynamic mobile phase conditions on chemically modified silica. J Chromatogr. 1988 Dec 23;458:255-66. doi: 10.1016/s0021-9673(00)90569-7.
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.
Cynthia Campbell, PhD
Kaiser Permanente Division of Research
239 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2015
First Posted
July 14, 2015
Study Start
December 2015
Actual (reported)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
Contact the study team to confirm eligibility.
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.
Primary Completion
May 2019
Actual (reported)Study Completion
May 2019
Actual (reported)Last Updated
September 26, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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