Integrating Buprenorphine Into the SFGH AIDS Program

NCT00263458 | Completed Phase 4 DMC

• 1 other identifier: H97HA03799
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the feasibility, cost, and effectiveness of a model of care designed to integrate buprenorphine treatment for opioid dependence into the HIV primary care clinics at the UCSF Positive Health Program.

Conditions

HIV; Buprenorphine; Opioid Dependence

Keywords

HIV; acquired immunodeficiency syndrome; buprenorphine; opioid dependence; opioid-related disorders; integrated care; primary care

Outcome Measures

Primary Outcomes (2)

• Substance use outcomes at 0, 1, 3, 6, 9 and 12 months.

  0, 1, 3, 6, 9 and 12 months.

• HIV care outcomes at 0, 1, 3, 6, 9 and 12 months.

  0, 1, 3, 6, 9 and 12 months

Secondary Outcomes (5)

• HIV-related health

  baseline, 1, 3, 6, 9 and 12 months

• Quality of life

  0, 1, 3, 6, 9 and 12 months

• Social functioning

  0, 1, 3, 6, 9 and 12 months

• Quality of HIV care.

  0, 3, 6, 9 and 12 months

• Patient satisfaction at 3 months.

  3 months

Study Arms (2)

Integrated

EXPERIMENTAL

Buprenorphine maintenance treatment delivered at an HIV primary care clinic

Other: Integrated office-based buprenorphine treatment for opioid dependence in an HIV primary care setting

Non-integrated

ACTIVE COMPARATOR

Buprenorphine maintenance treatment delivered at a public health substance use disorder clinic

Other: Integrated office-based buprenorphine treatment for opioid dependence in an HIV primary care setting

Interventions

Integrated office-based buprenorphine treatment for opioid dependence in an HIV primary care setting OTHER

Eligible opioid-dependent HIV-infected patients are randomly assigned to receive buprenorphine opioid agonist treatment for 12 months either in an integrated HIV primary care setting (intervention group) versus a non-integrated substance use treatment clinic setting (comparison group).

Also known as: Suboxone, Subutex

Integrated; Non-integrated

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Fluent in English
• Receive HIV primary care at the UCSF Positive Health Program
• Meet DSM-IVR criteria for opioid dependence

You may not qualify if:

• Plan to stay in the San Francisco Bay Area for the next 12 months
• Severe hepatic dysfunction, i.e., AST and/or ALT \> 5X upper limit of normal
• DSM-IV criteria for benzodiazepine abuse or dependence within the past 6 months
• DSM-IV criteria for alcohol dependence within the past 6 months
• Actively suicidal
• Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic)
• Methadone or opiate analgesic doses exceed level allowing for safe transition to buprenorphine
• Pregnant women and women actively trying to become pregnant
• Potential subjects also will be excluded for:
• Any medical condition(s), which, in the opinion of the investigator, would interfere with the patient's ability to participate in or adhere to the requirements of this study
• Unable or who decline to provide informed consent for the evaluation

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Department of Public Health: collaborator
• The New York Academy of Medicine: collaborator
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

UCSF Positive Health Program

San Francisco, California, 94110, United States

Location

Related Publications (11)

• Korthuis PT, Fiellin DA, Fu R, Lum PJ, Altice FL, Sohler N, Tozzi MJ, Asch SM, Botsko M, Fishl M, Flanigan TP, Boverman J, McCarty D; BHIVES Collaborative. Improving adherence to HIV quality of care indicators in persons with opioid dependence: the role of buprenorphine. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1(Suppl 1):S83-90. doi: 10.1097/QAI.0b013e31820bc9a5.

  PMID: 21317600 RESULT

• Sullivan LE, Botsko M, Cunningham CO, O'Connor PG, Hersh D, Mitty J, Lum PJ, Schottenfeld RS, Fiellin DA; BHIVES Collaborative. The impact of cocaine use on outcomes in HIV-infected patients receiving buprenorphine/naloxone. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1(Suppl 1):S54-61. doi: 10.1097/QAI.0b013e3182097576.

  PMID: 21317595 RESULT

• Fiellin DA, Weiss L, Botsko M, Egan JE, Altice FL, Bazerman LB, Chaudhry A, Cunningham CO, Gourevitch MN, Lum PJ, Sullivan LE, Schottenfeld RS, O'Connor PG; BHIVES Collaborative. Drug treatment outcomes among HIV-infected opioid-dependent patients receiving buprenorphine/naloxone. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1(0 1):S33-8. doi: 10.1097/QAI.0b013e3182097537.

  PMID: 21317592 RESULT

• Altice FL, Bruce RD, Lucas GM, Lum PJ, Korthuis PT, Flanigan TP, Cunningham CO, Sullivan LE, Vergara-Rodriguez P, Fiellin DA, Cajina A, Botsko M, Nandi V, Gourevitch MN, Finkelstein R; BHIVES Collaborative. HIV treatment outcomes among HIV-infected, opioid-dependent patients receiving buprenorphine/naloxone treatment within HIV clinical care settings: results from a multisite study. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1(Suppl 1):S22-32. doi: 10.1097/QAI.0b013e318209751e.

  PMID: 21317590 RESULT

• Vergara-Rodriguez P, Tozzi MJ, Botsko M, Nandi V, Altice F, Egan JE, O'Connor PG, Sullivan LE, Fiellin DA; BHIVES Collaborative. Hepatic safety and lack of antiretroviral interactions with buprenorphine/naloxone in HIV-infected opioid-dependent patients. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S62-7. doi: 10.1097/QAI.0b013e31820a820f.

  PMID: 21317596 RESULT

• Weiss L, Netherland J, Egan JE, Flanigan TP, Fiellin DA, Finkelstein R, Altice FL; BHIVES Collaborative. Integration of buprenorphine/naloxone treatment into HIV clinical care: lessons from the BHIVES collaborative. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S68-75. doi: 10.1097/QAI.0b013e31820a8226.

  PMID: 21317597 RESULT

• Finkelstein R, Netherland J, Sylla L, Gourevitch MN, Cajina A, Cheever L; BHIVES Collaborative. Policy implications of integrating buprenorphine/naloxone treatment and HIV care. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S98-S104. doi: 10.1097/QAI.0b013e31820a9a97.

  PMID: 21317602 RESULT

• Chaudhry AA, Botsko M, Weiss L, Egan JE, Mitty J, Estrada B, Lucas GM, Woodson T, Flanigan TP, Fiellin DA; BHIVES Collaborative. Participant characteristics and HIV risk behaviors among individuals entering integrated buprenorphine/naloxone and HIV care. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S14-21. doi: 10.1097/QAI.0b013e318209d3b9.

  PMID: 21317589 RESULT

• Weiss L, Egan JE, Botsko M, Netherland J, Fiellin DA, Finkelstein R. The BHIVES collaborative: organization and evaluation of a multisite demonstration of integrated buprenorphine/naloxone and HIV treatment. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S7-13. doi: 10.1097/QAI.0b013e3182097426.

  PMID: 21317598 RESULT

• Cheever LW, Kresina TF, Cajina A, Lubran R. A model federal collaborative to increase patient access to buprenorphine treatment in HIV primary care. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S3-6. doi: 10.1097/QAI.0b013e318209740f.

  PMID: 21317591 RESULT

• Friedland G, Vlahov D. Integration of buprenorphine for substance-abuse treatment by HIV care providers. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S1-2. doi: 10.1097/QAI.0b013e31820bc9ba. No abstract available.

  PMID: 21317588 RESULT

Related Links

• The UCSF Positive Health Program at the University of California San Francisco
• Integrated Buprenorphine \& HIV Care Evaluation and Support Center
• Community Behavioral Health Services, San Francisco Department of Public Health
• JAIDS. March 1, 2011 - Volume 56 - Supplement 1, Integration of Buprenorphine/Naloxone Treatment into HIV Clinical Care

MeSH Terms

Conditions

Opioid-Related Disorders; Acquired Immunodeficiency Syndrome

Interventions

Buprenorphine, Naloxone Drug Combination; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Paula J Lum, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 8, 2005
• Study Start: December 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

US (1)