STRIDE: HIV, Buprenorphine, and the Criminal Justice System

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01550341
• Collaborator: George Mason University (Other), Howard University (Other), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 57.2
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome; Opiate Addiction; Drug Dependence	Drug: Buprenorphine/naloxone; Drug: Placebo Oral Tablet	N/A

Detailed Description

Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months.

STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HIV, Buprenorphine, and the Criminal Justice System
• Actual Study Start Date: Feb 23, 2012
• Actual Primary Completion Date: Nov 30, 2015
• Actual Study Completion Date: Nov 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Buprenorphine	Drug: Buprenorphine/naloxone; 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.; Other Names: Suboxone
Placebo Comparator: Placebo	Drug: Placebo Oral Tablet; 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.

Outcome Measures

Primary Outcome Measures

1. CD4 Count Absolute [Baseline]

   CD4 Count Absolute

2. CD4 Count Absolute [6 Months]

   CD4 Count Absolute

3. CD4 Count Absolute [12 Months]

   CD4 Count

4. CD4 Percent [Baseline]

   CD4 Percent

5. CD4 Percent [6 Months]

   CD4 Percent

6. CD4 Percent [12 Months]

   CD4 Percent

7. Viral Load [Baseline]

   Viral Load

8. Viral Load [6 Months]

   Viral Load

9. Viral Load [12 Months]

   Viral Load

10. Log Viral Load [Baseline]

    Log Viral Load

11. Log Viral Load [6 Months]

    Log Viral Load

12. Log Viral Load [12 Months]

    Log Viral Load

Secondary Outcome Measures

1. Improved Opioid Treatment Outcomes [baseline, 3 months, 9 months, 12 months]

   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.

2. Improved Criminal Justice Outcomes [baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HIV+

• Age ≥18 yrs

• Meets DSM-IV criteria for opioid dependence

• Has medical entitlements in DC

• Able to provide informed consent

• Able to communicate in English or Spanish

Exclusion Criteria:

• Being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition

• Currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine

• AST and ALT >5x the upper limit of normal (AST≥175, ALT≥195)

• Pregnant or unwilling to use contraception (including OCPs, patch, Depo-Provera, condoms, etc.)

• Breastfeeding or unwilling to stop breastfeeding

• Subject is part of another pharmacological research study

• Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction)

• Suicidal ideation

• Hypersensitivity to buprenorphine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Howard University	Washington	District of Columbia	United States	20060

Sponsors and Collaborators

• Yale University
• George Mason University
• Howard University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Frederick Altice, MD, Yale University School of Medicine/AIDS Program
• Principal Investigator: Faye Taxman, PhD, George Mason University
• Principal Investigator: William Lawson, MD, Howard University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01550341
• Other Study ID Numbers: 1011007631; R01DA030768
• First Posted: Mar 12, 2012
• Last Update Posted: May 6, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Yale University: HIV; AIDS; Opiate Addiction; Drug Dependence; Buprenorphine
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Substance-Related Disorders; Opioid-Related Disorders; Behavior, Addictive; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Buprenorphine	Placebo	Total
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	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 of all reporting groups
Overall Participants	32	18	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	32 100%	17 94.4%	49 98%
>=65 years	0 0%	1 5.6%	1 2%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	51.29 (6.54)	55.59 (5.26)	52.81 (6.41)
Sex: Female, Male (Count of Participants)
Female	9 28.1%	5 27.8%	14 28%
Male	23 71.9%	13 72.2%	36 72%
Region of Enrollment (Count of Participants)
United States	32 100%	18 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	CD4 Count Absolute
Description	CD4 Count Absolute
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	31	13
Mean (Standard Deviation) [cells/uL]	486.15 (308.34)	403.92 (233.89)

2. Primary Outcome

Title	CD4 Count Absolute
Description	CD4 Count Absolute
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	31	18
Mean (Standard Deviation) [cells/uL]	455.52 (289.74)	551.23 (82.12)

3. Primary Outcome

Title	CD4 Count Absolute
Description	CD4 Count
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	31	18
Mean (Standard Deviation) [cells/uL]	490.25 (298.65)	492.33 (260.43)

4. Primary Outcome

Title	CD4 Percent
Description	CD4 Percent
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	31	13
Mean (Standard Deviation) [CD4 Percent]	23.36 (8.56)	25.7 (12.38)

5. Primary Outcome

Title	CD4 Percent
Description	CD4 Percent
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	31	13
Mean (Standard Deviation) [CD4 Percent]	21.33 (1.88)	28.56 (12.1)

6. Primary Outcome

Title	CD4 Percent
Description	CD4 Percent
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	32	18
Mean (Standard Deviation) [CD4 Percent]	22.14 (9.6)	27.95 (12.14)

7. Primary Outcome

Title	Viral Load
Description	Viral Load
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	32	18
Mean (Standard Deviation) [IU/mL]	1465.00 (551.17)	896.50 (1569.7)

8. Primary Outcome

Title	Viral Load
Description	Viral Load
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	32	18
Mean (Standard Deviation) [IU/mL]	9269.04 (4778.9)	7891.08 (26598.95)

9. Primary Outcome

Title	Viral Load
Description	Viral Load
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	32	18
Mean (Standard Deviation) [IU/mL]	8122.10 (18268.77)	19425.71 (51342.69)

10. Primary Outcome

Title	Log Viral Load
Description	Log Viral Load
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	32	18
Mean (Standard Deviation) [log(IU/mL)]	2.12 (1.02)	2.00 (.97)

11. Primary Outcome

Title	Log Viral Load
Description	Log Viral Load
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	32	18
Mean (Standard Deviation) [log(IU/mL)]	2.22 (1.35)	1.79 (1.11)

12. Primary Outcome

Title	Log Viral Load
Description	Log Viral Load
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Participants with complete lab results.

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	32	18
Mean (Standard Deviation) [log(IU/mL)]	2.40 (1.33)	1.84 (1.44)

13. Secondary Outcome

Title	Improved Opioid Treatment Outcomes
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.
Time Frame	baseline, 3 months, 9 months, 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	0	0

14. Secondary Outcome

Title	Improved Criminal Justice Outcomes
Description	Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.
Time Frame	baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Buprenorphine	Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Measure Participants	0	00000

Adverse Events

Arm/Group Title	Buprenorphine		Placebo
Arm/Group Description	Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.		Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
All Cause Mortality
	Buprenorphine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/18 (0%)
Serious Adverse Events
	Buprenorphine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Buprenorphine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.