NCT01841931

Brief Summary

The purpose of this study is to examine whether buprenorphine can be at least as effective as other opioid medications in relieving chronic pain in patients who suffer from dependence on their opioid medications, while patients simultaneously experience progressive decline of pain along with absence of opioid withdrawal symptoms and improved quality of life.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

April 23, 2018

Completed
Last Updated

May 8, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

January 25, 2013

Results QC Date

March 23, 2018

Last Update Submit

April 16, 2026

Conditions

Opioid DependenceChronic PainOpioid Use Disorder

Keywords

OpioidsDependenceBuprenorphinePain

Outcome Measures

Primary Outcomes (2)

  • Opiate Withdrawal

    Goal that patients will have NO withdrawal symptoms by the completion of their 3-day buprenorphine induction,and will remain withdrawal-free for the entire study duration. Assessed using Clinical Opiate Withdrawal Scale (COWS).

    6 months

  • Pain Severity

    Pain severity will be measured using a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine), adopted from the Brief Pain Inventory (BPI). No results to report.

    6 months

Secondary Outcomes (3)

  • Psychiatric Distress

    6 months

  • Quality of Life, Quality of Life is Measured

    6 months

  • Positive Affect

    6 months

Study Arms (1)

Buprenorphine Treatment

EXPERIMENTAL

Sublingual buprenorphine/naloxone taken in a 3-day induction, with a final daily dose (up to 32 mg depending on the subject) taken daily, as prescribed by the study psychiatrist. Subjects will continue buprenorphine for study duration (6 months).

Drug: Buprenorphine/Naloxone

Interventions

Buprenorphine/NaloxoneDRUG

Sublingual buprenorphine/naloxone taken in a 3 day induction, with a final daily dose (up to 32 mg depending on the subject) taken daily, as prescribed by the study psychiatrist. Subjects will continue buprenorphine for study duration (6 months).

Also known as: Buprenorphine, Suboxone
Buprenorphine Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM criteria for opioid dependence (or opioid use disorder when DSM 5 is in use)
  • Has received opioid therapy for at least 90 days
  • Has opioid dependence as assessed by a Maimonides psychiatrist

You may not qualify if:

  • Scheduled for major surgery during study duration
  • Predicted life expectancy \< 1 year
  • Plan to cease habitation in greater New York area within 6 months
  • Risks for buprenorphine outweigh potential benefit, as determined by the PI
  • Lacks sufficient fluency in English to understand the study protocol, answer survey questions or give informed consent
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (8)

  • TEDS. Treatment Episode Data Set, 1998-2008. Subsance Abuse and Mental Health Services Administration, Office of Applied Studies, http://wwwdasis.samhsa.gov/webt/NewMapv1.htm

    BACKGROUND

  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PMID: 10109801BACKGROUND

  • Walsh SL, Preston KL, Stitzer ML, Cone EJ, Bigelow GE. Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clin Pharmacol Ther. 1994 May;55(5):569-80. doi: 10.1038/clpt.1994.71.

    PMID: 8181201BACKGROUND

  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PMID: 3397865BACKGROUND

  • Rosen CS, Drescher KD, Moos RH, Finney JW, Murphy RT, Gusman F. Six- and ten-item indexes of psychological distress based on the Symptom Checklist-90. Assessment. 2000 Jun;7(2):103-11. doi: 10.1177/107319110000700201.

    PMID: 10868247BACKGROUND

  • Sobell, L.C., & Sobell, M.B., Alcohol Timeline Followback (TFLB), in Handbook or Psychiatric Measures, I.A.P.A. (ed.), Editor. 2000, American Psychiatric Association: Washington, D.C. p. 477-479.

    BACKGROUND

  • Lee JD, Grossman E, DiRocco D, Gourevitch MN. Home buprenorphine/naloxone induction in primary care. J Gen Intern Med. 2009 Feb;24(2):226-32. doi: 10.1007/s11606-008-0866-8. Epub 2008 Dec 17.

    PMID: 19089508BACKGROUND

  • Schilthuizen M, Stouthamer R. Horizontal transmission of parthenogenesis-inducing microbes in Trichogramma wasps. Proc Biol Sci. 1997 Mar 22;264(1380):361-6. doi: 10.1098/rspb.1997.0052.

    PMID: 9107051BACKGROUND

Related Links

MeSH Terms

Conditions

Opioid-Related DisordersChronic PainPain

Interventions

Buprenorphine, Naloxone Drug CombinationBuprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Limitations and Caveats

Major limitation of this study is the small number of participants. Early termination lead to small numbers of subject enrollment and only baseline data was collected. No data collection at 6 months or thereafter. Study was prematurely terminated as the PI left the institution. No adverse events. No results to report.

Results Point of Contact

Title
Director of Research, Department of Psychiatry
Organization
Maimonides Medical Center
tjacob@maimo.org
718-283-7162

Study Officials

  • Theresa Jacob, PhD, MPH

    Maimonides Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

January 25, 2013

First Posted

April 29, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

May 8, 2026

Results First Posted

April 23, 2018

Record last verified: 2026-04

Locations

US(1)