Substance-related DisordersPhase 4NCT00317460
Buprenorphine and Integrated HIV Care
A Phase 4 study testing Physician Management and Counseling in people with Substance-related Disorders and Drug Addiction, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-related Disorders, Drug Addiction, Human Immunodeficiency Virus
- What is being tested?
- Physician Management and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 disease
- DSM-IV criteria for opioid dependence, as assessed by SCID
- Documented opioid positive urine toxicology testing
Who cannot join
- Desire to remain enrolled in opioid agonist treatment at an opioid treatment program
- Current dependence on alcohol, benzodiazepines or sedatives (patients who are receiving benzodiazepines under the care of a psychiatrist for the treatment of an anxiety disorder will not be excluded)
- Current suicide or homicide risk
- Current psychotic disorder or major depression
- Inability to read or understand English
- Dementia
- Life-threatening or unstable medical problems requiring inpatient medical care or nursing home placement
- Currently enrolled in other studies involving the provision of psychosocial treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06519
About this study
Official title: On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings
The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting.
Read the detailed description
The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting. The proposed study will compare Physician Management (PM), a manual-guided brief intervention that approximates the usual counseling provided by primary care practitioners to patients with chronic medical conditions vs. an enhanced strategy of PM with the addition of a combined drug counseling and adherence management strategy (PM+DC/AM). DC is designed to educate the patient about the recovery process and provide additional advice about lifestyle changes including HIV transmission risk reduction and 12-step participation. Adherence Management (AM) is a counseling strategy focusing on HIV medication adherence, adapted from Sorensen et al1. This research will build on pilot work that is being completed in order to further develop and refine these counseling interventions, determine what other psychosocial interventions might be required, and to evaluate this model of integrated care in terms of its effects on opioid agonist therapy retention, decreasing illicit drug use, and increasing adherence to highly active antiretroviral therapy (HAART). Finally, it will provide data that will aid in the formulation of guidelines and the creation of practical manuals for optimizing the provision of this novel therapy to individuals with HIV disease and opioid dependence, as well as provide data for future funded randomized clinical trials.
From September 2005 (start date) to December 1, 2007, the study was conducted as part of a multi-site project that was overseen by the New York Academy of Medicine (NYAM), which is in charge of data analysis. Following December 1, 2007, the study will continue as a local, single-site project without further collaboration from NYAM.
- Conditions
- Substance-related Disorders, Drug Addiction, Human Immunodeficiency Virus, AIDS, HIV Infections
- Being tested
- Physician Management, Counseling
- Keywords
- Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine, Opiate Addiction
- Medical subject headings
- Substance-Related Disorders, Acquired Immunodeficiency Syndrome, HIV Infections, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician ManagementOther
Standard physician care
CounselingBehavioural
Physician Management and Counseling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Physician Management Receives: Other: Physician Management |
| 2 | Experimental | Physician Management and counseling (drug counseling and medication adherence) Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment retention
Measured: 52 weeks
Reductions in illicit opioid use
Measured: 52 weeks
Adherence to antiretroviral medications
Measured: 52 weeks
Secondary outcomes (6)
T-lymphocyte CD4 cell count
Measured: 52 weeks
HIV-1 RNA levels
Measured: 52 weeks
Reduction in HIV transmission risk behaviors
Measured: 52 weeks
Improved health status
Measured: 52 weeks
Patient satisfaction
Measured: 52 weeks
Provider satisfaction
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startSep 2005
- Primary completionOct 2009
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-related DisordersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- The New York Academy of Medicine
- Responsible party
- Sponsor
- Investigators
- Christopher J Cutter, Ph.D., Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317460
- Sponsor's protocol ID
- 0510000681
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2006
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings
- ClinicalTrials.gov ID
- NCT00317460
- Acronym / sponsor ID
- 0510000681
- Conditions
- Substance-related Disorders, Drug Addiction, Human Immunodeficiency Virus, AIDS, HIV Infections
- Keywords
- Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- The New York Academy of Medicine
- Study start
- Sep 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting.
Detailed description
The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting. The proposed study will compare Physician Management (PM), a manual-guided brief intervention that approximates the usual counseling provided by primary care practitioners to patients with chronic medical conditions vs. an enhanced strategy of PM with the addition of a combined drug counseling and adherence management strategy (PM+DC/AM). DC is designed to educate the patient about the recovery process and provide additional advice about lifestyle changes including HIV transmission risk reduction and 12-step participation. Adherence Management (AM) is a counseling strategy focusing on HIV medication adherence, adapted from Sorensen et al1. This research will build on pilot work that is being completed in order to further develop and refine these counseling interventions, determine what other psychosocial interventions might be required, and to evaluate this model of integrated care in terms of its effects on opioid agonist therapy retention, decreasing illicit drug use, and increasing adherence to highly active antiretroviral therapy (HAART). Finally, it will provide data that will aid in the formulation of guidelines and the creation of practical manuals for optimizing the provision of this novel therapy to individuals with HIV disease and opioid dependence, as well as provide data for future funded randomized clinical trials.
From September 2005 (start date) to December 1, 2007, the study was conducted as part of a multi-site project that was overseen by the New York Academy of Medicine (NYAM), which is in charge of data analysis. Following December 1, 2007, the study will continue as a local, single-site project without further collaboration from NYAM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Physician ManagementPhysician Management |
| 2 | Experimental | Behavioral: CounselingPhysician Management and counseling (drug counseling and medication adherence) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV disease
- DSM-IV criteria for opioid dependence, as assessed by SCID
- Documented opioid positive urine toxicology testing
Key exclusion criteria (8 listed)
- Desire to remain enrolled in opioid agonist treatment at an opioid treatment program
- Current dependence on alcohol, benzodiazepines or sedatives (patients who are receiving benzodiazepines under the care of a psychiatrist for the treatment of an anxiety disorder will not be excluded)
- Current suicide or homicide risk
- Current psychotic disorder or major depression
- Inability to read or understand English
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 |
|---|---|---|
| Physician ManagementStandard physician care | Other | 1 |
| CounselingPhysician Management and Counseling | Behavioural | 2 |
Primary outcome
Treatment retention
Time frame: 52 weeks
Reductions in illicit opioid use
Time frame: 52 weeks
Adherence to antiretroviral medications
Time frame: 52 weeks
6 secondary outcomes
T-lymphocyte CD4 cell count
Time frame: 52 weeks
HIV-1 RNA levels
Time frame: 52 weeks
Reduction in HIV transmission risk behaviors
Time frame: 52 weeks
Improved health status
Time frame: 52 weeks
Patient satisfaction
Time frame: 52 weeks
Provider satisfaction
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
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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.
Christopher J Cutter, Ph.D. study director
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physician Management and Counseling in people with Substance-related Disorders and Drug Addiction, 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 3 inclusion and 8 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 3 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment retention (time frame: 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2020.