Opiate AddictionPhase 4NCT00879996
Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
A Phase 4 study testing Methadone and Buprenorphine/naloxone in people with Opiate Addiction, run by State University of New York at Buffalo at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- Methadone and Buprenorphine/naloxone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Oct 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sheehan Memorial Hospital
Buffalo, New York, 14203
Erie County Medical Center
Buffalo, New York, 14215
About this study
Official title: A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
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.
Read the 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).
- Conditions
- Opiate Addiction
- Being tested
- Methadone, Buprenorphine/naloxone
- Keywords
- Opiate Addiction, Narcotic Addiction, Drug Addiction, Pain
- Medical subject headings
- Opioid-Related Disorders, Narcotic-Related Disorders, Substance-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Also called Dolophine
Oral, 10-60 mg per day, 2-4 times per day, 6 months
Buprenorphine/naloxoneDrug
Also called Suboxone
Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Methadone 10-60 mg per day in 2-4 divided doses for 6 months Receives: Drug: Methadone |
| 2 | Experimental | Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg) Receives: Drug: Buprenorphine/naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Retained in Treatment
This outcome assesses the number of participants who completed the treatment after 6 months.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 6 months
Self-reported Illicit Opioid Use
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 posted13 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2011
- Study completionOct 2011
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 (2)Papers the sponsor has linked to this study.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Richard Blondell, State University of New York at Buffalo
- Investigators
- Richard D Blondell, MD, Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879996
- Sponsor's protocol ID
- FMD0350908A
- Other IDs
- K23AA015616, R03DA029768
- Status last verified
- Aug 2012
- First submitted
- 10 Apr 2009
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.
PubMed 36063082Neumann AM, Blondell RD, Jaanimagi U, Giambrone AK, Homish GG, Lozano JR, Kowalik U, Azadfard M. A preliminary study comparing methadone and buprenorphine in patients with chronic pain and coexistent opioid addiction. J Addict Dis. 2013;32(1):68-78. doi: 10.1080/10550887.2012.759872.
PubMed 23480249
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT00879996
- Acronym / sponsor ID
- FMD0350908A
- Conditions
- Opiate Addiction
- Keywords
- Opiate Addiction, Narcotic Addiction, Drug Addiction, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Posted 9 Jul 2012
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MethadoneMethadone 10-60 mg per day in 2-4 divided doses for 6 months |
| 2 | Experimental | Drug: Buprenorphine/naloxoneBuprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- chronic back pain
- opioid addiction
- not successful with abstinence
- at least 18 years old
- able to understand spoken English
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| MethadoneAlso: DolophineOral, 10-60 mg per day, 2-4 times per day, 6 months | Drug | 1 |
| Buprenorphine/naloxoneAlso: SuboxoneSub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months | Drug | 2 |
Primary outcome
Number of Participants Retained in Treatment
Time frame: 6 months
This outcome assesses the number of participants who completed the treatment after 6 months.
3 secondary outcomes
Numerical Rating Score for Pain
Time frame: 6 months
Numerical Rating Score for Functioning
Time frame: 6 months
Self-reported Illicit Opioid Use
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 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36063082Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.
- Derived from this study: PubMed 23480249Neumann AM, Blondell RD, Jaanimagi U, Giambrone AK, Homish GG, Lozano JR, Kowalik U, Azadfard M. A preliminary study comparing methadone and buprenorphine in patients with chronic pain and coexistent opioid addiction. J Addict Dis. 2013;32(1):68-78. doi: 10.1080/10550887.2012.759872.
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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.
Richard D Blondell, MD principal investigator
SUNY Buffalo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone and Buprenorphine/naloxone in people with Opiate Addiction, run by State University of New York at Buffalo at 2 sites 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 9 Jul 2012). 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?
Number of Participants Retained in Treatment (time frame: 6 months). 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 NCT00879996, which also lists 2 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 7 Aug 2012.