Opiate Substitution TreatmentNCT02496403
Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence
A study testing Standard Medical Management (SMM) in people with Opiate Substitution Treatment, run by Kaiser Permanente at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Substitution Treatment
- What is being tested?
- Standard Medical Management (SMM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Sacramento Chemical Dependency Recovery Program
Sacramento, California, 95821
About this study
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.
Read the 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.
- Conditions
- Opiate Substitution Treatment
- Being tested
- Standard Medical Management (SMM)
- Keywords
- buprenorphine-naloxone combination, Suboxone, Buprenorphine, Substance Use, Behavioral intervention, Opioid partial agonist, medication assisted therapy, opioid addiction
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Medical Management (SMM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 months
Secondary outcomes (6)
Chronic Pain using the pain Interference scale
The severity of chronic pain and the degree to which it interferes with every day life will be measured using the PROMIS Pain Interference scale.
Measured: 6 months
Quality of Life using PROMIS Global Health scale
Quality of life will be assessed by the PROMIS Global Health scale, which measures satisfaction with physical health, psychological health, and social relationships.
Measured: 6 months
Mental health using PHQ-9
Psychiatric problem severity will be measured by the PHQ-9, a 9-item measure of depression and anxiety symptoms.
Measured: 6 months
Chronic Pain using the pain Interference scale
The severity of chronic pain and the degree to which it interferes with every day life will be measured using the PROMIS Pain Interference scale.
Measured: 12 months
Mental health using PHQ-9
Psychiatric problem severity will be measured by the PHQ-9, a 9-item measure of depression and anxiety symptoms.
Measured: 12 months
Quality of Life using PROMIS Global Health scale
Quality of life will be assessed by the PROMIS Global Health scale, which measures satisfaction with physical health, psychological health, and social relationships.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Opiate Substitution TreatmentStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Cynthia Campbell, PhD, Principal investigator, Kaiser Permanente Division of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496403
- Sponsor's protocol ID
- CN-13-1592-H
- Other IDs
- R01DA036603
- Status last verified
- Sep 2019
- First submitted
- 6 Jul 2015
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 2853172International 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.
PubMed 2633651Haddad 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.
PubMed 23332439Stein 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.
PubMed 22093488Soeffing 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.
PubMed 19553061Manchikanti 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.
PubMed 20859312Kenan 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.
PubMed 23696768Graybill JR. Histoplasmosis and AIDS. J Infect Dis. 1988 Sep;158(3):623-6. doi: 10.1093/infdis/158.3.623. No abstract available.
PubMed 3045214Presl J. [Bioactive and immunoreactive gonadotropins]. Cesk Gynekol. 1986 Jun;51(5):354-8. No abstract available. Czech.
PubMed 3087632Sitges-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.
PubMed 3280087Heinen 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.
PubMed 2978198Kitagawa T, Pitot HC. Immunohistochemical demonstration of serine dehydratase in rat liver. Am J Pathol. 1975 Feb;78(2):309-18.
PubMed 163593Kuehn 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.
PubMed 17227967Coben 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.
PubMed 20409500Oakey RE. Steroid sulphatase deficiency. J Endocrinol. 1987 Mar;112(3):341-3. doi: 10.1677/joe.0.1120341. No abstract available.
PubMed 3470422
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence
- ClinicalTrials.gov ID
- NCT02496403
- Acronym / sponsor ID
- CN-13-1592-H
- Conditions
- Opiate Substitution Treatment
- Keywords
- buprenorphine-naloxone combination, Suboxone, Buprenorphine, Substance Use, Behavioral intervention, Opioid partial agonist, medication assisted therapy, opioid addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Management | Experimental | Behavioral: Standard Medical Management (SMM)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Standard Medical Management |
Primary outcome
Adherence to buprenorphine/naloxone using MPR
Time frame: 90-day
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.
Abstinence using ASI
Time frame: 6 months
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).
Health care utilization costs using ICER
Time frame: 12 months
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.
Adherence to buprenorphine/naloxone using drug testing
Time frame: 90-day
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.
Abstinence using ASI
Time frame: 12 months
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 secondary outcomes
Chronic Pain using the pain Interference scale
Time frame: 6 months
Quality of Life using PROMIS Global Health scale
Time frame: 6 months
Mental health using PHQ-9
Time frame: 6 months
Chronic Pain using the pain Interference scale
Time frame: 12 months
Mental health using PHQ-9
Time frame: 12 months
Quality of Life using PROMIS Global Health scale
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 2853172Miller 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.
- Background: PubMed 2633651International 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.
- Background: PubMed 23332439Haddad 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.
- Background: PubMed 22093488Stein 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.
- Background: PubMed 19553061Soeffing 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.
- Background: PubMed 20859312Manchikanti 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.
- Background: PubMed 23696768Kenan 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.
- Background: PubMed 3045214Graybill JR. Histoplasmosis and AIDS. J Infect Dis. 1988 Sep;158(3):623-6. doi: 10.1093/infdis/158.3.623. No abstract available.
- Background: PubMed 3087632Presl J. [Bioactive and immunoreactive gonadotropins]. Cesk Gynekol. 1986 Jun;51(5):354-8. No abstract available. Czech.
- Background: PubMed 3280087Sitges-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.
- Background: PubMed 2978198Heinen 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.
- Background: PubMed 163593Kitagawa T, Pitot HC. Immunohistochemical demonstration of serine dehydratase in rat liver. Am J Pathol. 1975 Feb;78(2):309-18.
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Active, not recruiting
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
Opioid-Related Disorders, Hepatitis C (HCV)
Enrolling by invitation
Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder
Opioid-Related Disorders, Mobile Applications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Campbell, PhD principal investigator
Kaiser Permanente Division of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Medical Management (SMM) in people with Opiate Substitution Treatment, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to buprenorphine/naloxone using MPR (time frame: 90-day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02496403, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.