Trial Outcomes & Findings for Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients (NCT NCT00879996)

NCT ID: NCT00879996

Last Updated: 2012-08-07

Results Overview

This outcome assesses the number of participants who completed the treatment after 6 months.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 54 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2012-08-07

Participant Flow

Participant milestones

Measure	Methadone Methadone 10-60 mg per day in 2-4 divided doses for 6 months	Buprenorphine/Naloxone Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Overall Study STARTED	28	26
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	15	13

Reasons for withdrawal

Measure	Methadone Methadone 10-60 mg per day in 2-4 divided doses for 6 months	Buprenorphine/Naloxone Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
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

Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

Baseline characteristics by cohort

Measure	Methadone n=28 Participants Methadone 10-60 mg per day in 2-4 divided doses for 6 months	Buprenorphine/Naloxone n=26 Participants Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	37.7 years STANDARD_DEVIATION 8.6 • n=5 Participants	39.0 years STANDARD_DEVIATION 10.9 • n=7 Participants	38.3 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	26 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All participants that were randomized were analyzed regarding their retention in treatment at 6 months.

This outcome assesses the number of participants who completed the treatment after 6 months.

Outcome measures

Measure	Methadone n=28 Participants Methadone 10-60 mg per day divided in 2-4 doses for 6 months	Buprenorphine/Naloxone n=26 Participants Buprenorphine 4-16 mg per day divided in 2-4 doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Number of Participants Retained in Treatment	13 participants	13 participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants that completed the treatment at 6 months were analyzed.

Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.

Outcome measures

Measure	Methadone n=13 Participants Methadone 10-60 mg per day divided in 2-4 doses for 6 months	Buprenorphine/Naloxone n=13 Participants Buprenorphine 4-16 mg per day divided in 2-4 doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Numerical Rating Score for Pain	5.4 units on a 0-10 NRS scale Standard Deviation 1.1	5.6 units on a 0-10 NRS scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 6 months

Population: The participants who completed the treatment were included in the statistical analysis.

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.

Outcome measures

Measure	Methadone n=13 Participants Methadone 10-60 mg per day divided in 2-4 doses for 6 months	Buprenorphine/Naloxone n=13 Participants Buprenorphine 4-16 mg per day divided in 2-4 doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Numerical Rating Score for Functioning	5.0 units on a 0-10 point NRS scale Standard Deviation 1.7	5.3 units on a 0-10 point NRS scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Methadone n=13 Participants Methadone 10-60 mg per day divided in 2-4 doses for 6 months	Buprenorphine/Naloxone n=13 Participants Buprenorphine 4-16 mg per day divided in 2-4 doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Self-reported Illicit Opioid Use	0 number of participants	5 number of participants

Adverse Events

Methadone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Buprenorphine/Naloxone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard Blondell

SUNY Buffalo

Phone: 716-898-4971

Email: blondell@buffalo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place