Human Immunodeficiency VirusSTRIDENCT01550341

HIV, Buprenorphine, and the Criminal Justice System

A study testing Buprenorphine/naloxone in people with Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction
What is being tested?: Buprenorphine/naloxone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 23 Feb 2012to 30 Nov 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction)
Suicidal ideation
Hypersensitivity to buprenorphine

Trial locations and contacts

1 site in 1 country.

United States1 site

Howard University
Washington D.C., District of Columbia, 20060

Other trials in United States

About this study

Read the 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.

Conditions: Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence
Being tested: Buprenorphine/naloxone, Placebo Oral Tablet
Keywords: HIV, AIDS, Opiate Addiction, Drug Dependence, Buprenorphine
Medical subject headings: Acquired Immunodeficiency Syndrome, Opioid-Related Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Buprenorphine/naloxoneDrug
Also called Suboxone
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Placebo Oral TabletDrug
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.

Study groups in NCT01550341
Study group	Role	What they receive
Buprenorphine	Active comparator	Not described Receives: Drug: Buprenorphine/naloxone
Placebo	Placebo comparator	Not described Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

CD4 Count Absolute
CD4 Count Absolute
Measured: Baseline
CD4 Count Absolute
CD4 Count Absolute
Measured: 6 Months
CD4 Count Absolute
CD4 Count
Measured: 12 Months
CD4 Percent
CD4 Percent
Measured: Baseline
CD4 Percent
CD4 Percent
Measured: 6 Months
CD4 Percent
CD4 Percent
Measured: 12 Months
Viral Load
Viral Load
Measured: Baseline
Viral Load
Viral Load
Measured: 6 Months
Viral Load
Viral Load
Measured: 12 Months
Log Viral Load
Log Viral Load
Measured: Baseline
Log Viral Load
Log Viral Load
Measured: 6 Months
Log Viral Load
Log Viral Load
Measured: 12 Months

Secondary outcomes (2)

Improved Opioid Treatment Outcomes
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.
Measured: baseline, 3 months, 9 months, 12 months
Improved Criminal Justice Outcomes
Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.
Measured: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 201230 Nov 2016

First posted12 Mar 2012 (estimated)
Study start23 Feb 2012
Primary completion30 Nov 2015
Study completion30 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01550341
Sponsor's protocol ID: 1011007631
Other IDs: R01DA030768
Acronym: STRIDE
Status last verified: Apr 2020
First submitted: 21 Jun 2011
Last updated: 6 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HIV, Buprenorphine, and the Criminal Justice System
ClinicalTrials.gov ID: NCT01550341
Acronym / sponsor ID: STRIDE / 1011007631
Conditions: Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence
Keywords: HIV, AIDS, Opiate Addiction, Drug Dependence, Buprenorphine
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: George Mason University, Howard University, National Institute on Drug Abuse (NIDA)
Study start: 23 Feb 2012 (actual)
Primary completion: 30 Nov 2015 (actual)
Study completion: 30 Nov 2016 (actual)
First posted: 12 Mar 2012 (estimated)
Results: Posted 6 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Buprenorphine	Active comparator	Drug: Buprenorphine/naloxone
Placebo	Placebo comparator	Drug: Placebo Oral Tablet

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

HIV+
Age ≥18 yrs
Meets DSM-IV criteria for opioid dependence
Has medical entitlements in DC
Able to provide informed consent

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Buprenorphine/naloxoneAlso: Suboxone2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Drug	Buprenorphine
Placebo Oral Tablet2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.	Drug	Placebo

Primary outcome

CD4 Count Absolute
Time frame: Baseline
CD4 Count Absolute
CD4 Count Absolute
Time frame: 6 Months
CD4 Count Absolute
CD4 Count Absolute
Time frame: 12 Months
CD4 Count
CD4 Percent
Time frame: Baseline
CD4 Percent
CD4 Percent
Time frame: 6 Months
CD4 Percent
CD4 Percent
Time frame: 12 Months
CD4 Percent
Viral Load
Time frame: Baseline
Viral Load
Viral Load
Time frame: 6 Months
Viral Load
Viral Load
Time frame: 12 Months
Viral Load
Log Viral Load
Time frame: Baseline
Log Viral Load
Log Viral Load
Time frame: 6 Months
Log Viral Load
Log Viral Load
Time frame: 12 Months
Log Viral Load

2 secondary outcomes

Improved Opioid Treatment Outcomes
Time frame: baseline, 3 months, 9 months, 12 months
Improved Criminal Justice Outcomes
Time frame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52

Results and safety

Results posted to the registry on 6 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Buprenorphine	32	32
Placebo	18	18

Primary outcome: CD4 Count Absolute

Time frame: Baseline. Mean (Standard Deviation). Unit: cells/uL

Measure	Buprenorphine n = 31	Placebo n = 13
Value	486.15 (308.34)	403.92 (233.89)

Population analysed: Participants with complete lab results.

Primary outcome: CD4 Count Absolute

Time frame: 6 Months. Mean (Standard Deviation). Unit: cells/uL

Measure	Buprenorphine n = 31	Placebo n = 18
Value	455.52 (289.74)	551.23 (82.12)

Population analysed: Participants with complete lab results.

Primary outcome: CD4 Count Absolute

Time frame: 12 Months. Mean (Standard Deviation). Unit: cells/uL

Measure	Buprenorphine n = 31	Placebo n = 18
Value	490.25 (298.65)	492.33 (260.43)

Population analysed: Participants with complete lab results.

Primary outcome: CD4 Percent

Time frame: Baseline. Mean (Standard Deviation). Unit: CD4 Percent

Measure	Buprenorphine n = 31	Placebo n = 13
Value	23.36 (8.56)	25.7 (12.38)

Population analysed: Participants with complete lab results.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Buprenorphine	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Placebo	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Human Immunodeficiency Virus

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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frederick Altice, MD principal investigator

Yale University School of Medicine/AIDS Program

Faye Taxman, PhD principal investigator

George Mason University

William Lawson, MD principal investigator

Howard University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Buprenorphine/naloxone in people with Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD4 Count Absolute (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01550341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.