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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
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The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with standard medical management. This will be examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization treatment for those who do not respond successfully to the initial treatment; and c) a long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.
This is a randomized 2-phase, open-label; multi-center study conducted in outpatient treatment settings. The main objective of this study is to identify an effective sublingual buprenorphine/naloxone treatment regimen for subjects dependent on prescription opioids. Phase 1 of this study will assess the prevailing one-month detoxification practice. This phase will assess the benefits of individual drug counseling in a short-term treatment paradigm. The second phase of this study will assess the benefit of individual drug counseling in a longer-term treatment paradigm for participants who did not respond successfully to the short-term buprenorphine/naloxone treatment. There is also a long-term follow-up assessment to determine outcomes at 1.5 years, 2.5 years, and 3.5 years after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine/Nx with EMM | Experimental |
| |
| Buprenorphine/Nx with SMM | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Medical Management (SMM) of Prescription Opiate Abuse | Behavioral | Standard Medical Management in Phase 1 will consist of one hour-long initial visit; one individual 15-20 minute visit later in Week 1; one individual 15-20 minute visit per week through the end of Week 4; one 15-20 minute SMM visit at Week 6 and at Week 8. And in Phase 2, one 30-60 minute initial visit; one 15-20 minute follow-up visit later in Week 1; one individual session (15-20 minutes) per week through Week 12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 | In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks. | 12 weeks |
| The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment | In phase 2, successful outcome was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11). This outcome measure required substantial improvement but not complete abstinence. | 12 weeks in Phase 2 period (i.e., 24 weeks into the study) |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up | A planned secondary outcome, successful outcome at week 24, that is, 8 weeks after completion of buprenorphine-naloxone taper, was defined the same as at week 12 of Phase 2, that is abstinent from opioids during week 24 and at least 2 of the previous 3 weeks. | 24 weeks in Phase 2 period (i.e., 36 weeks into the study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Weiss, M.D. | Mclean Hospital | Principal Investigator |
| Walter Ling, M.D. | University of California, Las Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrated Substance Abuse Programs | Los Angeles | California | 90025 | United States | ||
| San Francisco General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20116457 | Background | Weiss RD, Potter JS, Provost SE, Huang Z, Jacobs P, Hasson A, Lindblad R, Connery HS, Prather K, Ling W. A multi-site, two-phase, Prescription Opioid Addiction Treatment Study (POATS): rationale, design, and methodology. Contemp Clin Trials. 2010 Mar;31(2):189-99. doi: 10.1016/j.cct.2010.01.003. Epub 2010 Jan 29. | |
| 20079463 | Background |
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653 treatment-seeking outpatients dependent on prescription opioids across 10 U.S. sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine/Nx With EMM | All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 (12 Weeks) |
|
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| Enhanced Medical Management (EMM) of Prescription Opiate Abuse | Behavioral | Enhanced Medical Management in Phase 1 will consist of SMM plus two individual sessions with a counselor per week (45 minutes each) through Weeks 1-4, and one 45-minute counseling visit at Week 6 and at Week 8. And in Phase 2, EMM will consist of the SMM plus two individual sessions with a counselor per week (45 minutes each) during Weeks 1-6 and one individual session with a counselor per week (45 minutes each) during Weeks 7-12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four. |
|
| The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition | As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain "other than everyday kinds of pain" excluding withdrawal-related pain, for at least 3 months. | 12 weeks |
| The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition | As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain "other than everyday kinds of pain" excluding withdrawal-related pain, for at least 3 months. | 12 weeks |
| The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1 | As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome. | 12 weeks |
| The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2 | As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome. | 12 weeks |
| San Francisco |
| California |
| 94110 |
| United States |
| East Indiana Treatment Center | Lawrenceburg | Indiana | 47025 | United States |
| McLean Hospital, Alcohol and Drug Abuse Treatment Program | Belmont | Massachusetts | 02478 | United States |
| North Shore - Long Island Jewish Health Systems | Glen Oaks | New York | 11004 | United States |
| Bellevue Hospital Center | New York | New York | 10016 | United States |
| St. Luke's Roosevelt Hospital Center | New York | New York | 10019 | United States |
| ADAPT, Inc. | Roseburg | Oregon | 97470 | United States |
| Behavioral Health Services of Pickens County | Pickens | South Carolina | 29671 | United States |
| Homeward Bound, Inc. | Dallas | Texas | 75208 | United States |
| Providence Behavioral Health Service | Everett | Washington | 98206 | United States |
| Chestnut Ridge Hospital | Morgantown | West Virginia | 26505 | United States |
| Potter JS, Prather K, Kropp F, Byrne M, Sullivan CR, Mohamedi N, Copersino ML, Weiss RD. A method to diagnose opioid dependence resulting from heroin versus prescription opioids using the Composite International Diagnostic Interview. Contemp Clin Trials. 2010 Mar;31(2):185-8. doi: 10.1016/j.cct.2010.01.002. Epub 2010 Jan 14. |
| 20163386 | Background | Weiss RD, Potter JS, Copersino ML, Prather K, Jacobs P, Provost S, Chim D, Selzer J, Ling W. Conducting clinical research with prescription opioid dependence: defining the population. Am J Addict. 2010 Mar-Apr;19(2):141-6. doi: 10.1111/j.1521-0391.2009.00017.x. |
| 20558415 | Background | Upadhyay J, Maleki N, Potter J, Elman I, Rudrauf D, Knudsen J, Wallin D, Pendse G, McDonald L, Griffin M, Anderson J, Nutile L, Renshaw P, Weiss R, Becerra L, Borsook D. Alterations in brain structure and functional connectivity in prescription opioid-dependent patients. Brain. 2010 Jul;133(Pt 7):2098-114. doi: 10.1093/brain/awq138. Epub 2010 Jun 16. |
| 23333292 | Background | Dreifuss JA, Griffin ML, Frost K, Fitzmaurice GM, Potter JS, Fiellin DA, Selzer J, Hatch-Maillette M, Sonne SC, Weiss RD. Patient characteristics associated with buprenorphine/naloxone treatment outcome for prescription opioid dependence: Results from a multisite study. Drug Alcohol Depend. 2013 Jul 1;131(1-2):112-8. doi: 10.1016/j.drugalcdep.2012.12.010. Epub 2013 Jan 18. |
| 22065255 | Result | Weiss RD, Potter JS, Fiellin DA, Byrne M, Connery HS, Dickinson W, Gardin J, Griffin ML, Gourevitch MN, Haller DL, Hasson AL, Huang Z, Jacobs P, Kosinski AS, Lindblad R, McCance-Katz EF, Provost SE, Selzer J, Somoza EC, Sonne SC, Ling W. Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial. Arch Gen Psychiatry. 2011 Dec;68(12):1238-46. doi: 10.1001/archgenpsychiatry.2011.121. Epub 2011 Nov 7. |
| 40833692 | Derived | McHugh RK, Bailey AJ, McConaghy BA, Weiss RD, Fiellin DA, Hillhouse M, Moore BA, Fitzmaurice GM. Behavioral Therapy as an Adjunct to Buprenorphine Treatment for Opioid Use Disorder: A Secondary Analysis of 4 Randomized Clinical Trials. JAMA Netw Open. 2025 Aug 1;8(8):e2528529. doi: 10.1001/jamanetworkopen.2025.28529. |
| 38616571 | Derived | Brandt L, Odom GJ, Hu MC, Castro C, Balise RR; CTN-0094 Team. Empirically contrasting urine drug screening-based opioid use disorder treatment outcome definitions. Addiction. 2024 Jul;119(7):1289-1300. doi: 10.1111/add.16494. Epub 2024 Apr 14. |
| 31715440 | Derived | McDermott KA, Griffin ML, McHugh RK, Fitzmaurice GM, Jamison RN, Provost SE, Weiss RD. Long-term naturalistic follow-up of chronic pain in adults with prescription opioid use disorder. Drug Alcohol Depend. 2019 Dec 1;205:107675. doi: 10.1016/j.drugalcdep.2019.107675. Epub 2019 Oct 28. |
| 30920187 | Derived | Weiss RD, Griffin ML, Marcovitz DE, Hilton BT, Fitzmaurice GM, McHugh RK, Carroll KM. Correlates of Opioid Abstinence in a 42-Month Posttreatment Naturalistic Follow-Up Study of Prescription Opioid Dependence. J Clin Psychiatry. 2019 Mar 26;80(2):18m12292. doi: 10.4088/JCP.18m12292. |
| 25562462 | Derived | McDermott KA, Griffin ML, Connery HS, Hilario EY, Fiellin DA, Fitzmaurice GM, Weiss RD. Initial response as a predictor of 12-week buprenorphine-naloxone treatment response in a prescription opioid-dependent population. J Clin Psychiatry. 2015 Feb;76(2):189-94. doi: 10.4088/JCP.14m09096. |
| 25189089 | Derived | Potter JS, Dreifuss JA, Marino EN, Provost SE, Dodd DR, Rice LS, Fitzmaurice GM, Griffin ML, Weiss RD. The multi-site prescription opioid addiction treatment study: 18-month outcomes. J Subst Abuse Treat. 2015 Jan;48(1):62-9. doi: 10.1016/j.jsat.2014.07.009. Epub 2014 Aug 2. |
| 24219166 | Derived | Griffin ML, Dodd DR, Potter JS, Rice LS, Dickinson W, Sparenborg S, Weiss RD. Baseline characteristics and treatment outcomes in prescription opioid dependent patients with and without co-occurring psychiatric disorder. Am J Drug Alcohol Abuse. 2014 Mar;40(2):157-62. doi: 10.3109/00952990.2013.842241. Epub 2013 Nov 12. |
| FG001 |
| Buprenorphine/Nx With SMM |
All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine. |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 2 (24 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine/Nx With EMM | All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional. |
| BG001 | Buprenorphine/Nx With SMM | All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 | In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks. | 653 study participants randomized to Phase 1 were included in analysis. | Posted | Number | participants | 12 weeks |
|
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| |||||||||||||||||||||||||||||
| Secondary | The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up | A planned secondary outcome, successful outcome at week 24, that is, 8 weeks after completion of buprenorphine-naloxone taper, was defined the same as at week 12 of Phase 2, that is abstinent from opioids during week 24 and at least 2 of the previous 3 weeks. | 360 participants randomized to Phase 2 were included in the analysis. | Posted | Number | participants | 24 weeks in Phase 2 period (i.e., 36 weeks into the study) |
| |||||||||||||||||||||||||||||||
| Secondary | The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition | As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain "other than everyday kinds of pain" excluding withdrawal-related pain, for at least 3 months. | 379 identified as having chronic pain at baseline in Phase 1. | Posted | Number | participants | 12 weeks |
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| Secondary | The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition | As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain "other than everyday kinds of pain" excluding withdrawal-related pain, for at least 3 months. | Posted | Number | participants | 12 weeks |
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| |||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1 | As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome. | Participants randomized to Phase 1 were stratified by two variables: current chronic pain and lifetime heroin use. | Posted | Number | participants | 12 weeks |
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| ||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2 | As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome. | Posted | Number | participants | 12 weeks |
|
| |||||||||||||||||||||||||||||||
| Primary | The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment | In phase 2, successful outcome was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11). This outcome measure required substantial improvement but not complete abstinence. | 360 participants randomized to Phase 2 were included in the analysis. | Posted | Number | participants | 12 weeks in Phase 2 period (i.e., 24 weeks into the study) |
|
Adverse Events were captured beginning at the time of randomization and every subsequent research visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buprenorphine/Nx With EMM | All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional. | 6 | 329 | 277 | 329 | ||
| EG001 | Buprenorphine/Nx With SMM | All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine. | 5 | 324 | 265 | 324 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | MeDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MeDRA | Systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MeDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MeDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MeDRA | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MeDRA | Systematic Assessment |
| |
| Grand Mal Convulsion | Nervous system disorders | MeDRA | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MeDRA | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MeDRA | Systematic Assessment |
| |
| Ovarian Torsion | Reproductive system and breast disorders | MeDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MeDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MeDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MeDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MeDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MeDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MeDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MeDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MeDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MeDRA | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MeDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MeDRA | Systematic Assessment |
|
A treatment providing infrequent or no medical management was not included. It is not known if less intensive medical management would affect outcomes. Length of the trial may have also affected results. Pain severity was only moderate on average.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger D. Weiss, M.D. | McLean Hospital/Harvard Medical School | 617-855-2242 | rweiss@mclean.harvard.edu |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| >=65 years |
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| Male |
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