Trial Outcomes & Findings for Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients (NCT NCT01841931)

Results Overview

Goal that patients will have NO withdrawal symptoms by the completion of their 3-day buprenorphine induction,and will remain withdrawal-free for the entire study duration. Assessed using Clinical Opiate Withdrawal Scale (COWS).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

6 months

Results posted on

2026-05-08

Participant Flow

Terminated

Not completed

Participant milestones

Participant milestones
Measure	Buprenorphine Treatment Enrolled patients for buprenorphine treatment
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Buprenorphine Treatment Enrolled patients for buprenorphine treatment
Overall Study Study terminated	4

Baseline Characteristics

Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buprenorphine Treatment n=3 Participants Enrolled patients undergoing buprenorphine treatment
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=41 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants
Sex: Female, Male Female	2 Participants n=41 Participants
Sex: Female, Male Male	1 Participants n=41 Participants
Region of Enrollment United States	3 Participants n=41 Participants
Pain severity	7 units on a scale n=41 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Study terminated prematurely

Goal that patients will have NO withdrawal symptoms by the completion of their 3-day buprenorphine induction,and will remain withdrawal-free for the entire study duration. Assessed using Clinical Opiate Withdrawal Scale (COWS).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Enrolled patients

Pain severity will be measured using a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine), adopted from the Brief Pain Inventory (BPI). No results to report.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Enrolled patients

The investigators will utilize the SCL-6 (Symptoms Checklist 6, a validated abbreviated version of the SCL-90) to assess patients' psychological well being.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study terminated prematurely

Investigators will use the QOL (EuroQol EQ5D) questionnaire, which assess patients' self-assessment of health and health-related quality of life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Enrolled patients

The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).

Outcome measures

Outcome data not reported

Adverse Events

Patient

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

Director of Research, Department of Psychiatry

Maimonides Medical Center

Phone: 718-283-7162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place