Trial Outcomes & Findings for HIV, Buprenorphine, and the Criminal Justice System (NCT NCT01550341)

NCT ID: NCT01550341

Last Updated: 2020-05-06

Results Overview

CD4 Count Absolute

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Baseline

Results posted on

2020-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Buprenorphine Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Overall Study STARTED	32	18
Overall Study COMPLETED	32	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV, Buprenorphine, and the Criminal Justice System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buprenorphine n=32 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=18 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Total n=50 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	32 Participants n=5 Participants	17 Participants n=7 Participants	49 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	51.29 Years STANDARD_DEVIATION 6.54 • n=5 Participants	55.59 Years STANDARD_DEVIATION 5.26 • n=7 Participants	52.81 Years STANDARD_DEVIATION 6.41 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	13 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants	18 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Participants with complete lab results.

CD4 Count Absolute

Outcome measures

Outcome measures
Measure	Buprenorphine n=31 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=13 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
CD4 Count Absolute	486.15 cells/uL Standard Deviation 308.34	403.92 cells/uL Standard Deviation 233.89

PRIMARY outcome

Timeframe: 6 Months

Population: Participants with complete lab results.

CD4 Count Absolute

Outcome measures

Outcome measures
Measure	Buprenorphine n=31 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=18 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
CD4 Count Absolute	455.52 cells/uL Standard Deviation 289.74	551.23 cells/uL Standard Deviation 82.12

PRIMARY outcome

Timeframe: 12 Months

Population: Participants with complete lab results.

CD4 Count

Outcome measures

Outcome measures
Measure	Buprenorphine n=31 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=18 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
CD4 Count Absolute	490.25 cells/uL Standard Deviation 298.65	492.33 cells/uL Standard Deviation 260.43

PRIMARY outcome

Timeframe: Baseline

Population: Participants with complete lab results.

CD4 Percent

Outcome measures

Outcome measures
Measure	Buprenorphine n=31 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=13 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
CD4 Percent	23.36 CD4 Percent Standard Deviation 8.56	25.7 CD4 Percent Standard Deviation 12.38

PRIMARY outcome

Timeframe: 6 Months

Population: Participants with complete lab results.

CD4 Percent

Outcome measures

Outcome measures
Measure	Buprenorphine n=31 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=13 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
CD4 Percent	21.33 CD4 Percent Standard Deviation 1.88	28.56 CD4 Percent Standard Deviation 12.1

PRIMARY outcome

Timeframe: 12 Months

Population: Participants with complete lab results.

CD4 Percent

Outcome measures

Outcome measures
Measure	Buprenorphine n=32 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=18 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
CD4 Percent	22.14 CD4 Percent Standard Deviation 9.6	27.95 CD4 Percent Standard Deviation 12.14

PRIMARY outcome

Timeframe: Baseline

Population: Participants with complete lab results.

Viral Load

Outcome measures

Outcome measures
Measure	Buprenorphine n=32 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=18 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Viral Load	1465.00 IU/mL Standard Deviation 551.17	896.50 IU/mL Standard Deviation 1569.7

PRIMARY outcome

Timeframe: 6 Months

Population: Participants with complete lab results.

Viral Load

Outcome measures

Outcome measures
Measure	Buprenorphine n=32 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=18 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Viral Load	9269.04 IU/mL Standard Deviation 4778.9	7891.08 IU/mL Standard Deviation 26598.95

PRIMARY outcome

Timeframe: 12 Months

Population: Participants with complete lab results.

Viral Load

Outcome measures

Outcome measures
Measure	Buprenorphine n=32 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=18 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Viral Load	8122.10 IU/mL Standard Deviation 18268.77	19425.71 IU/mL Standard Deviation 51342.69

PRIMARY outcome

Timeframe: Baseline

Population: Participants with complete lab results.

Log Viral Load

Outcome measures

Outcome measures
Measure	Buprenorphine n=32 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=18 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Log Viral Load	2.12 log(IU/mL) Standard Deviation 1.02	2.00 log(IU/mL) Standard Deviation .97

PRIMARY outcome

Timeframe: 6 Months

Population: Participants with complete lab results.

Log Viral Load

Outcome measures

Outcome measures
Measure	Buprenorphine n=32 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=18 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Log Viral Load	2.22 log(IU/mL) Standard Deviation 1.35	1.79 log(IU/mL) Standard Deviation 1.11

PRIMARY outcome

Timeframe: 12 Months

Population: Participants with complete lab results.

Log Viral Load

Outcome measures

Outcome measures
Measure	Buprenorphine n=32 Participants Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo n=18 Participants Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Log Viral Load	2.40 log(IU/mL) Standard Deviation 1.33	1.84 log(IU/mL) Standard Deviation 1.44

SECONDARY outcome

Timeframe: baseline, 3 months, 9 months, 12 months

Population: This outcome was not collected and analyzed due to the change in study design (see study description).

Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52

Population: These data were never collected and summarized due to the change in study design (see study description).

Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.

Outcome measures

Outcome data not reported

Adverse Events

Buprenorphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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. Frederick Altice, Principal Investigator

Yale University

Phone: 203-737-2883

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place