Trial Outcomes & Findings for Buprenorphine as a Treatment in Opiate Dependent Pain Patients (NCT NCT00552578)

Results Overview

Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Six months

Results posted on

2011-02-17

Participant Flow

12 participants recruited Dec 2007 to Apr 2008

Participant milestones

Participant milestones
Measure	Tapering Doses of Buprenorphine Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Steady Dose of Buprenorphine Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Overall Study STARTED	6	6
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tapering Doses of Buprenorphine Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Steady Dose of Buprenorphine Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Buprenorphine as a Treatment in Opiate Dependent Pain Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tapering Doses of Buprenorphine n=6 Participants Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Steady Dose of Buprenorphine n=6 Participants Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.	Total n=12 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	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	44 years STANDARD_DEVIATION 6 • n=5 Participants	46 years STANDARD_DEVIATION 15 • n=7 Participants	45 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months

Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.

Outcome measures

Outcome measures
Measure	Tapering Doses of Buprenorphine n=5 Participants Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Steady Dose of Buprenorphine n=5 Participants Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Relapse to Substance Abuse	2 participants	4 participants

SECONDARY outcome

Timeframe: Baseline and six months

Population: Reported value (number) was the number who reported a "better" overall quality-of-life to the question: "How would you describe your overall level of function now as compared to the time right before you started the study?" Responses were recorded as: "better," "no change," or "worse."

Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.

Outcome measures

Outcome measures
Measure	Tapering Doses of Buprenorphine n=5 Participants Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Steady Dose of Buprenorphine n=5 Participants Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Six months

Population: Analysis was intent-to-treat.

"Treatment retention" was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses).

Outcome measures

Outcome measures
Measure	Tapering Doses of Buprenorphine n=6 Participants Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Steady Dose of Buprenorphine n=6 Participants Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Treatment Retention.	0 Participants	5 Participants

Adverse Events

Tapering Doses of Buprenorphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Steady Dose of Buprenorphine

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

R Blondell

SUNY Buffalo

Phone: 716-898-4971

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place