Clinical trial NCT00316277: Prescription Opioid Addiction Treatment Study (POATS)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opiate Dependence
Substance-related Disorders
Opioid-related Disorders
Keywords: Opiate Analgesic Dependence
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2006-04-20
Enrollment: 653
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1
timeFrame: 12 weeks
measure: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment
timeFrame: 12 weeks in Phase 2 period (i.e., 24 weeks into the study)
Secondary outcomes:
measure: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up
timeFrame: 24 weeks in Phase 2 period (i.e., 36 weeks into the study)
measure: The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition
timeFrame: 12 weeks
measure: The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition
timeFrame: 12 weeks
measure: The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1
timeFrame: 12 weeks
measure: The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Integrated Substance Abuse Programs
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: Lawrenceburg
country: United States
facility: East Indiana Treatment Center
state: Indiana
city: Belmont
country: United States
facility: McLean Hospital, Alcohol and Drug Abuse Treatment Program
state: Massachusetts
city: Glen Oaks
country: United States
facility: North Shore - Long Island Jewish Health Systems
state: New York
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
city: Roseburg
country: United States
facility: ADAPT, Inc.
state: Oregon
city: Pickens
country: United States
facility: Behavioral Health Services of Pickens County
state: South Carolina
city: Dallas
country: United States
facility: Homeward Bound, Inc.
state: Texas
city: Everett
country: United States
facility: Providence Behavioral Health Service
state: Washington
city: Morgantown
country: United States
facility: Chestnut Ridge Hospital
state: West Virginia
Study officials:
affiliation: Mclean Hospital
name: Roger Weiss, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Las Angeles
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.