Prescription Opioid Addiction Treatment Study (POATS)

NCT00316277 | Completed Phase 3 Results DMC

• 1 other identifier: NIDA-CTN-0030
• Study Type: interventional
• Target: 653
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Opiate Dependence; Substance-related Disorders; Opioid-related Disorders

Keywords

Opiate Analgesic Dependence

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (5)

• The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up

  24 weeks in Phase 2 period (i.e., 36 weeks into the study)

• The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition

  12 weeks

• The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition

  12 weeks

• The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1

  12 weeks

• The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2

  12 weeks

Study Arms (2)

Buprenorphine/Nx with EMM

EXPERIMENTAL

Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse

Buprenorphine/Nx with SMM

ACTIVE COMPARATOR

Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse

Interventions

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.

Buprenorphine/Nx with SMM

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.

Buprenorphine/Nx with EMM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Physically dependent on opioids
• Meet DSM-IV criteria for opioid dependence

You may not qualify if:

• Known allergy or sensitivity to buprenorphine or naloxone
• Unstable psychiatric disorder
• Pregnant or lactating females
• Liver function test results greater than 5 times the upper limit of normal range

Sponsors & Collaborators

• Mclean Hospital: lead
• University of California, Los Angeles: collaborator

Study Sites (12)

Integrated Substance Abuse Programs

Los Angeles, California, 90025, United States

Location

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

East Indiana Treatment Center

Lawrenceburg, Indiana, 47025, United States

Location

McLean Hospital, Alcohol and Drug Abuse Treatment Program

Belmont, Massachusetts, 02478, United States

Location

North Shore - Long Island Jewish Health Systems

Glen Oaks, New York, 11004, United States

Location

Bellevue Hospital Center

New York, New York, 10016, United States

Location

St. Luke's Roosevelt Hospital Center

New York, New York, 10019, United States

Location

ADAPT, Inc.

Roseburg, Oregon, 97470, United States

Location

Behavioral Health Services of Pickens County

Pickens, South Carolina, 29671, United States

Location

Homeward Bound, Inc.

Dallas, Texas, 75208, United States

Location

Providence Behavioral Health Service

Everett, Washington, 98206, United States

Location

Chestnut Ridge Hospital

Morgantown, West Virginia, 26505, United States

Location

Related Publications (13)

• 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.

  PMID: 20116457 BACKGROUND

• 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.

  PMID: 20079463 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.

  PMID: 20163386 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.

  PMID: 20558415 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.

  PMID: 23333292 BACKGROUND

• 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.

  PMID: 22065255 RESULT

• 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.

  PMID: 40833692 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.

  PMID: 38616571 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.

  PMID: 31715440 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.

  PMID: 30920187 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.

  PMID: 25562462 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.

  PMID: 25189089 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.

  PMID: 24219166 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Roger D. Weiss, M.D.
• Organization: McLean Hospital/Harvard Medical School

rweiss@mclean.harvard.edu

617-855-2242

Study Officials

• Roger Weiss, M.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

• Walter Ling, M.D.

  University of California, Las Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Divsion of Alcohol and Drug Abuse; Professor of Psychiatry

Study Record Dates

• First Submitted: April 18, 2006
• First Posted: April 20, 2006
• Study Start: May 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2013
• Last Updated: February 6, 2013
• Results First Posted: July 27, 2012

Record last verified: 2013-02

Locations

US (12)