Trial Outcomes & Findings for Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans (NCT NCT01096550)

NCT ID: NCT01096550

Last Updated: 2020-04-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 319 participants
• Primary outcome timeframe: 6 months post-baseline
• Results posted on: 2020-04-08

Participant Flow

New patients entering buprenorphine treatment at one of the two participating outpatient "drug-free" treatment programs were block randomized to either intensive outpatient treatment (IOP) or standard outpatient treatment (OP). The study initially included a third clinic site, which was dropped due to insufficient enrollment at that site.

345 patients were randomized. Of those, the following participants were excluded from the study shortly after random assignment: 21 were from the discontinued site, 2 were dropped because of non-standard clinic treatment track, 1 voluntarily withdrew, 2 were erroneously re-enrolled. We also excluded 19 non-African Americans, per study protocol.

Participant milestones

Measure	Intensive Outpatient Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.	Outpatient Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
Overall Study STARTED	170	175
Overall Study COMPLETED	133	146
Overall Study NOT COMPLETED	37	29

Reasons for withdrawal

Measure	Intensive Outpatient Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.	Outpatient Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
Overall Study discontinued site	10	11
Overall Study non-regular treatment track at clinic	1	1
Overall Study clinic readmission	1	1
Overall Study Withdrawal by Subject	0	1
Overall Study non-African American participant	13	6
Overall Study Lost to Follow-up	12	9

Baseline Characteristics

Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

Baseline characteristics by cohort

Measure	Intensive Outpatient n=170 Participants Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.	Outpatient n=175 Participants Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.	Total n=345 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	168 Participants n=5 Participants	174 Participants n=7 Participants	342 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	44.15 years STANDARD_DEVIATION 8.15 • n=5 Participants	46.27 years STANDARD_DEVIATION 6.75 • n=7 Participants	45.23 years STANDARD_DEVIATION 7.53 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	67 Participants n=7 Participants	129 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	108 Participants n=7 Participants	216 Participants n=5 Participants
Region of Enrollment United States	170 participants n=5 Participants	175 participants n=7 Participants	345 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post-baseline

Outcome measures

Measure	Intensive Outpatient n=145 Participants Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.	Outpatient n=155 Participants Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)	20 percentage of opioid dependent subjects	21 percentage of opioid dependent subjects

Adverse Events

Intensive Outpatient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Outpatient

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. Shannon Gwin Mitchell

Friends Research Institute

Phone: 410-837-3977

Email: smitchell@friendsresearch.org

Results disclosure agreements

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