Opioid Use DisorderPhase 4NCT01841931
Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients
A Phase 4 study testing Buprenorphine/Naloxone in people with Opioid Use Disorder and Opioid Dependence, run by Theresa Jacob, PhD, MPH at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Opioid Dependence, Chronic Pain
- What is being tested?
- Buprenorphine/Naloxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Buprenorphine Tx:A Safe Alternative for Opioid Dependent Pain Patients
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.
Read the detailed description
The study will utilize sublingual buprenorphine for the treatment of chronic pain patients with co-occurring opioid dependence. Adult male and female chronic pain patients with co-occurring opioid dependence/disorder, being treated at MMC will be enrolled in a home induction procedure. Subjects will be switched from their current opioid pain medication to buprenorphine/naloxone to assess whether buprenorphine is at least as effective, if not more effective, as other opioid medications in controlling their pain while simultaneously improving their psychological distress, functional status, and other aspects of patients' lives. We will utilize a home induction procedure, and maintain subjects on this oral medication for a duration of 6 months.
- Conditions
- Opioid Use Disorder, Opioid Dependence, Chronic Pain
- Being tested
- Buprenorphine/Naloxone
- Keywords
- Opioids, Dependence, Buprenorphine, Pain
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine/NaloxoneDrug
Also called Buprenorphine, Suboxone
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Buprenorphine/Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
Psychiatric Distress
The investigators will utilize the SCL-6 (Symptoms Checklist 6, a validated abbreviated version of the SCL-90) to assess patients' psychological well being.
Measured: 6 months
Quality of Life, Quality of Life is Measured
Investigators will use the QOL (EuroQol EQ5D) questionnaire, which assess patients' self-assessment of health and health-related quality of life.
Measured: 6 months
Positive Affect
The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionAug 2013
Why it stopped: Principal Investigator is no longer at this site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theresa Jacob, PhD, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theresa Jacob, PhD, MPH, Maimonides Medical Center
- Investigators
- Theresa Jacob, PhD, MPH, Study director, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841931
- Sponsor's protocol ID
- 11/09/VA05
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2013
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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
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.
PubMed 10109801Walsh 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.
PubMed 8181201Watson 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.
PubMed 3397865Rosen 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.
PubMed 10868247Sobell, 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.
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.
PubMed 19089508Schilthuizen 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.
PubMed 9107051
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine Tx:A Safe Alternative for Opioid Dependent Pain Patients
- ClinicalTrials.gov ID
- NCT01841931
- Acronym / sponsor ID
- 11/09/VA05
- Conditions
- Opioid Use Disorder, Opioid Dependence, Chronic Pain
- Keywords
- Opioids, Dependence, Buprenorphine, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator is no longer at this site
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Theresa Jacob, PhD, MPHUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Posted 23 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will utilize sublingual buprenorphine for the treatment of chronic pain patients with co-occurring opioid dependence. Adult male and female chronic pain patients with co-occurring opioid dependence/disorder, being treated at MMC will be enrolled in a home induction procedure. Subjects will be switched from their current opioid pain medication to buprenorphine/naloxone to assess whether buprenorphine is at least as effective, if not more effective, as other opioid medications in controlling their pain while simultaneously improving their psychological distress, functional status, and other aspects of patients' lives. We will utilize a home induction procedure, and maintain subjects on this oral medication for a duration of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine Treatment | Experimental | Drug: Buprenorphine/NaloxoneSublingual 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine/NaloxoneAlso: Buprenorphine, SuboxoneSublingual 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 Treatment |
Primary outcome
Opiate Withdrawal
Time frame: 6 months
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).
Pain Severity
Time frame: 6 months
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.
3 secondary outcomes
Psychiatric Distress
Time frame: 6 months
Quality of Life, Quality of Life is Measured
Time frame: 6 months
Positive Affect
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundTEDS. 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: PubMed 10109801EuroQol 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.
- Background: PubMed 8181201Walsh 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.
- Background: PubMed 3397865Watson 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.
- Background: PubMed 10868247Rosen 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.
- BackgroundSobell, 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: PubMed 19089508Lee 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.
- Background: PubMed 9107051Schilthuizen 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.
- British Pain Society guidelines on prescribing opioids, intended for both doctors and patients.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Jacob, PhD, MPH study director
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine/Naloxone in people with Opioid Use Disorder and Opioid Dependence, run by Theresa Jacob, PhD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opiate Withdrawal (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01841931, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.