Opiate Addiction
Conditions
Keywords
Opiate Addiction, Narcotic Addiction, Drug Addiction, Pain
Brief summary
The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.
Detailed description
The purpose of this randomized clinical trial is to compare methadone with buprenorphine for the treatment of chronic pain among patients who have developed a physical dependence on prescription opiate analgesics that is associated with psychosocial dysfunction (i.e., addiction).
Interventions
DRUGMethadone
Oral, 10-60 mg per day, 2-4 times per day, 6 months
DRUGBuprenorphine/naloxone
Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* chronic back pain * opioid addiction * not successful with abstinence * at least 18 years old * able to understand spoken English * live in Western New York State (Erie or Niagara county) * have health insurance or ability to pay for health care * no methadone or buprenorphine treatment within past year * not member of a vulnerable population (e.g., pregnancy, prisoner)
Exclusion criteria
* homelessness * unable to give consent (e.g., dementia, psychosis) * serious heart or lung disease * taking a medication that could interact with methadone or buprenorphine * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Retained in Treatment | 6 months | This outcome assesses the number of participants who completed the treatment after 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Score for Pain | 6 months | Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible. |
| Numerical Rating Score for Functioning | 6 months | We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning. |
| Self-reported Illicit Opioid Use | 6 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methadone Methadone 10-60 mg per day in 2-4 divided doses for 6 months | 28 |
| Buprenorphine/Naloxone Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg) | 26 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 6 |
| Overall Study | non-compliance | 6 | 4 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | psychiatric problem | 0 | 1 |
| Overall Study | put on parole | 1 | 0 |
Baseline characteristics
| Characteristic | Buprenorphine/Naloxone | Methadone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 28 Participants | 53 Participants |
| Age Continuous | 39.0 years STANDARD_DEVIATION 10.9 | 37.7 years STANDARD_DEVIATION 8.6 | 38.3 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 26 participants | 28 participants | 54 participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 25 Participants |
| Sex: Female, Male Male | 17 Participants | 12 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 26 |
| serious Total, serious adverse events | 0 / 28 | 0 / 26 |
Outcome results
Primary
Number of Participants Retained in Treatment
This outcome assesses the number of participants who completed the treatment after 6 months.
Time frame: 6 months
Population: All participants that were randomized were analyzed regarding their retention in treatment at 6 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methadone | Number of Participants Retained in Treatment | 13 participants |
| Buprenorphine/Naloxone | Number of Participants Retained in Treatment | 13 participants |
Comparison: Null hypothesis: Methadone and buprenorphine treatment do not differ in treatment retention.p-value: 0.7795% CI: [0.4156, 2.007]Log Rank
Secondary
Numerical Rating Score for Functioning
We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning.
Time frame: 6 months
Population: The participants who completed the treatment were included in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methadone | Numerical Rating Score for Functioning | 5.0 units on a 0-10 point NRS scale | Standard Deviation 1.7 |
| Buprenorphine/Naloxone | Numerical Rating Score for Functioning | 5.3 units on a 0-10 point NRS scale | Standard Deviation 2 |
Comparison: null-hypothesis: methadone and buprenorphine treatment are equally effective in reducing self-reported functioning at 6 months.p-value: <0.665ANOVA
Secondary
Numerical Rating Score for Pain
Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.
Time frame: 6 months
Population: Participants that completed the treatment at 6 months were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methadone | Numerical Rating Score for Pain | 5.4 units on a 0-10 NRS scale | Standard Deviation 1.1 |
| Buprenorphine/Naloxone | Numerical Rating Score for Pain | 5.6 units on a 0-10 NRS scale | Standard Deviation 2.5 |
Comparison: Null hypothesis: Methadone treatment is as effective as buprenorphine treatment in reducing pain.p-value: <0.043ANOVA
Secondary
Self-reported Illicit Opioid Use
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methadone | Self-reported Illicit Opioid Use | 0 number of participants |
| Buprenorphine/Naloxone | Self-reported Illicit Opioid Use | 5 number of participants |
Comparison: Null hypothesis: methadone or buprenorphine treatment equally reduce illicit drug use.p-value: <0.039Fisher Exact