Prescription Opioid Addiction Treatment Study (POATS)

• ClinicalTrials.gov Identifier: NCT00316277
• Recruitment Status: Completed
• First Posted: April 20, 2006
• Results First Posted: July 27, 2012
• Last Update Posted: February 6, 2013
• Sponsor: Mclean Hospital
• Collaborator: University of California, Los Angeles
• Information provided by (Responsible Party): Roger D. Weiss, Mclean Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opiate Dependence; Substance-related Disorders; Opioid-related Disorders	Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse; Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse	Phase 3

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 653 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Standard Medical Management or Enhanced Medical Management for Opioid Analgesic Dependence
• Study Start Date: May 2006
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Buprenorphine/Nx with EMM	Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse; 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.
Active Comparator: Buprenorphine/Nx with SMM	Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse; 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.

Outcome Measures

Primary Outcome Measures :

1. The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 [ Time Frame: 12 weeks ]
   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.
2. The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment [ Time Frame: 12 weeks in Phase 2 period (i.e., 24 weeks into the study) ]
   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.

Secondary Outcome Measures :

1. The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up [ Time Frame: 24 weeks in Phase 2 period (i.e., 36 weeks into the study) ]
   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.
2. The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition [ Time Frame: 12 weeks ]
   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.
3. The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition [ Time Frame: 12 weeks ]
   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.
4. The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1 [ Time Frame: 12 weeks ]
   As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.
5. The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2 [ Time Frame: 12 weeks ]
   As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, California

Integrated Substance Abuse Programs

Los Angeles, California, United States, 90025

San Francisco General Hospital

San Francisco, California, United States, 94110

United States, Indiana

East Indiana Treatment Center

Lawrenceburg, Indiana, United States, 47025

United States, Massachusetts

McLean Hospital, Alcohol and Drug Abuse Treatment Program

Belmont, Massachusetts, United States, 02478

United States, New York

North Shore - Long Island Jewish Health Systems

Glen Oaks, New York, United States, 11004

Bellevue Hospital Center

New York, New York, United States, 10016

St. Luke's Roosevelt Hospital Center

New York, New York, United States, 10019

United States, Oregon

ADAPT, Inc.

Roseburg, Oregon, United States, 97470

United States, South Carolina

Behavioral Health Services of Pickens County

Pickens, South Carolina, United States, 29671

United States, Texas

Homeward Bound, Inc.

Dallas, Texas, United States, 75208

United States, Washington

Providence Behavioral Health Service

Everett, Washington, United States, 98206

United States, West Virginia

Chestnut Ridge Hospital

Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Mclean Hospital

University of California, Los Angeles

Investigators

• Principal Investigator: Roger Weiss, M.D.; Mclean Hospital
• Principal Investigator: Walter Ling, M.D.; University of California, Las Angeles

More Information

Publications of Results:

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.

Other Publications:

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

• Responsible Party: Roger D. Weiss, Chief Divsion of Alcohol and Drug Abuse; Professor of Psychiatry, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT00316277
• Other Study ID Numbers: NIDA-CTN-0030
• First Posted: April 20, 2006
• Results First Posted: July 27, 2012
• Last Update Posted: February 6, 2013
• Last Verified: February 2013

Keywords provided by Roger D. Weiss, Mclean Hospital:

Opiate Analgesic Dependence

Additional relevant MeSH terms:

Disease; Substance-Related Disorders; Opioid-Related Disorders; Pathologic Processes; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Opiate Alkaloids; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents