Chronic Pain, Opioid Dependence, Opioid Use Disorder
Conditions
Keywords
Opioids, Dependence, Buprenorphine, Pain
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.
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.
Interventions
DRUGBuprenorphine/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).
Sponsors
Theresa Jacob, PhD, MPH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opiate Withdrawal | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychiatric Distress | 6 months | The investigators will utilize the SCL-6 (Symptoms Checklist 6, a validated abbreviated version of the SCL-90) to assess patients' psychological well being. |
| Quality of Life, Quality of Life is Measured | 6 months | Investigators will use the QOL (EuroQol EQ5D) questionnaire, which assess patients' self-assessment of health and health-related quality of life. |
| Positive Affect | 6 months | The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale). |
Countries
United States
Contacts
STUDY_DIRECTORTheresa Jacob, PhD, MPH
Maimonides Medical Center
Participant flow
Recruitment details
Terminated
Pre-assignment details
Not completed
Participants by arm
| Arm | Count |
|---|---|
| Patient Enrolled patients | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Patient |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Pain severity | 7 units on a scale |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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
Primary
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
Population: Enrolled patients
Secondary
Positive Affect
The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).
Time frame: 6 months
Population: Enrolled patients
Secondary
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
Population: Enrolled patients
Secondary
Quality of Life
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
Population: Enrolled patients