A Phase 4 interventional study of Buprenorphine/Naloxone in Opioid Use Disorder, Opioid Dependence and Chronic Pain, sponsored by Theresa Jacob, PhD, MPH. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Theresa Jacob, PhD, MPH · Phase 4, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 4 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Theresa Jacob, PhD, MPH is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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
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).
Time frame: 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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 6 months
Positive Affect
The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).
Time frame: 6 months
Terminated
| Milestone | Buprenorphine Treatment |
|---|---|
| Started | 4 |
| Completed | 0 |
| Not completed | 4 |
| Withdrew: Study terminated | 4 |
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).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
The investigators will utilize the SCL-6 (Symptoms Checklist 6, a validated abbreviated version of the SCL-90) to assess patients' psychological well being.
No measurements were reported for this outcome.
Investigators will use the QOL (EuroQol EQ5D) questionnaire, which assess patients' self-assessment of health and health-related quality of life.
No measurements were reported for this outcome.
The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).
No measurements were reported for this outcome.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
Chronic pain patients with opioid dependence
| Age, Categorical(Participants) | Buprenorphine Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Buprenorphine Treatment |
|---|---|
| Female | 2 |
| Male | 1 |
| Region of Enrollment(Participants) | Buprenorphine Treatment |
|---|---|
| United States | 3 |
| Pain severity(units on a scale) | Buprenorphine Treatment |
|---|---|
| Mean | 7 (4 to 10) |
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Theresa Jacob, PhD, MPH