A Phase 4 interventional study of Methadone and Buprenorphine/naloxone in Opiate Addiction, sponsored by State University of New York at Buffalo. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-07.
Sponsored by State University of New York at Buffalo · Phase 4, Interventional, and Treatment
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.
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).
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 54 is close to the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Methadone 10-60 mg per day in 2-4 divided doses for 6 months
Drug: Methadone
Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Drug: Buprenorphine/naloxone
Oral, 10-60 mg per day, 2-4 times per day, 6 months
Also known as: Dolophine
Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months
Also known as: Suboxone
Number of Participants Retained in Treatment
This outcome assesses the number of participants who completed the treatment after 6 months.
Time frame: 6 months
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
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
Self-reported Illicit Opioid Use
Time frame: 6 months
| Milestone | Methadone | Buprenorphine/Naloxone |
|---|---|---|
| Started | 28 | 26 |
| Completed | 13 | 13 |
| Not completed | 15 | 13 |
| Withdrew: Lost to follow-up | 7 | 6 |
| Withdrew: Non-compliance | 6 | 4 |
| Withdrew: Physician decision | 1 | 2 |
| Withdrew: Psychiatric problem | 0 | 1 |
| Withdrew: Put on parole | 1 | 0 |
This outcome assesses the number of participants who completed the treatment after 6 months.
| participants | Methadone | Buprenorphine/Naloxone |
|---|---|---|
| Number of Participants Retained in Treatment | 13 | 13 |
Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.
| units on a 0-10 NRS scale | Methadone | Buprenorphine/Naloxone |
|---|---|---|
| Numerical Rating Score for Pain | 5.4 ± 1.1 | 5.6 ± 2.5 |
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.
| units on a 0-10 point NRS scale | Methadone | Buprenorphine/Naloxone |
|---|---|---|
| Numerical Rating Score for Functioning | 5.0 ± 1.7 | 5.3 ± 2.0 |
| number of participants | Methadone | Buprenorphine/Naloxone |
|---|---|---|
| Self-reported Illicit Opioid Use | 0 | 5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Methadone | — | 0/28 (0%) | 0/28 (0%) |
| Buprenorphine/Naloxone | — | 0/26 (0%) | 0/26 (0%) |
| Age, Categorical(Participants) | Methadone | Buprenorphine/Naloxone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 28 | 25 | 53 |
| >=65 years | 0 | 1 | 1 |
| Age Continuous(years) | Methadone | Buprenorphine/Naloxone | Total |
|---|---|---|---|
| Mean | 37.7 ± 8.6 | 39.0 ± 10.9 | 38.3 ± 9.7 |
| Sex: Female, Male(Participants) | Methadone | Buprenorphine/Naloxone | Total |
|---|---|---|---|
| Female | 16 | 9 | 25 |
| Male | 12 | 17 | 29 |
| Region of Enrollment(participants) | Methadone | Buprenorphine/Naloxone | Total |
|---|---|---|---|
| United States | 28 | 26 | 54 |
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo