Trial Outcomes & Findings for Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial (NCT NCT00684554)

Results Overview

The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

20 participants

Primary outcome timeframe

one week after initial primary care visit

Results posted on

2019-04-24

Participant Flow

Twenty patients were recruited between December 2007-June 2008 through referrals from clinical and research groups at Columbia University Medical Center and locally posted flyers.

After a structured telephone interview, participants completed in-person screening after obtaining informed consent. Of the 21 patients screened, one was excluded for active alcohol and benzodiazepine dependence.

Participant milestones

Participant milestones
Measure	Unobserved-at Home Buprenorphine Unobserved at home induction Buprenorphine: Dose is determined according to the participants' individual need.	Observed Buprenorphine Observed in office induction Buprenorphine: Dose is determined according to the participants' individual need.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unobserved-at Home n=10 Participants Buprenorphine Unobserved at home induction Buprenorphine: Dose is determined according to the participants' individual need.	Observed n=10 Participants Buprenorphine Observed in office induction Buprenorphine: Dose is determined according to the participants' individual need.	Total n=20 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	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: one week after initial primary care visit

Population: patients who in initiated induction

The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.

Outcome measures

Outcome measures
Measure	Unobserved-at Home n=10 Participants Buprenorphine Unobserved at home induction Buprenorphine: Dose is determined according to the participants' individual need.	Observed n=10 Participants Buprenorphine Observed in office induction Buprenorphine: Dose is determined according to the participants' individual need.
The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.	6 participants	6 participants

SECONDARY outcome

Timeframe: a) 2 days

Population: participants who initiated induction

participants experiencing prolonged withdrawal beyond two days after buprenorphine induction

Outcome measures

Outcome measures
Measure	Unobserved-at Home n=10 Participants Buprenorphine Unobserved at home induction Buprenorphine: Dose is determined according to the participants' individual need.	Observed n=10 Participants Buprenorphine Observed in office induction Buprenorphine: Dose is determined according to the participants' individual need.
Prolonged Withdrawal	3 participants	3 participants

Adverse Events

Unobserved-at Home

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Observed

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Unobserved-at Home n=10 participants at risk Buprenorphine Unobserved at home induction Buprenorphine: Dose is determined according to the participants' individual need.	Observed n=10 participants at risk Buprenorphine Observed in office induction Buprenorphine: Dose is determined according to the participants' individual need.
Gastrointestinal disorders Prolonged withdrawal	30.0% 3/10 • Number of events 3 • 12 weeks	30.0% 3/10 • Number of events 3 • 12 weeks

Additional Information

Dr. Frances Levin

New York State Psychiatric Institute

Phone: 646-774-6137

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place