Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain (CHOACOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272829
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital

Brief Summary:
This project will develop a novel collaborative treatment, based on the primary care behavioral consultation model and behavior therapy techniques including motivational interviewing and functional assessment, in which a patient, a Behavioral Health Consultant (BHC) and a HIV primary care provider share a unified plan targeting misuse of prescribed opioid analgesics in older HIV+ adults. The intervention will involve meetings between the BHC and the PCP, the BHC and the participant, and the BHC, PCP and the participant. Opioid misuse will be the primary outcome variable. Quality of the patient-provider relationship, pain, problematic use of other substances, antiretroviral adherence, and psychosocial functioning will be secondary outcomes.

Condition or disease Intervention/treatment Phase
Opioid Misuse Older Adults HIV Behavioral: Choacot: Behavioral Intervention for Chronic Opioid Use Other: Health Education Not Applicable

Detailed Description:

Up to 20% of HIV patients receive prescriptions for chronic opioid therapy (COT) to treat chronic pain. This project will develop a novel collaborative treatment, based on the primary care behavioral consultation model and behavior therapy techniques including motivational interviewing and functional assessment, in which a patient, a Behavioral Health Consultant and a HIV primary care provider share a unified plan targeting misuse of prescribed opioid analgesics in older HIV+ adults. This would be the first theoretically-driven, empirically-tested intervention that specifically attends to the difficult issues around chronic pain and opioid prescription in HIV clinical practice.

This project will develop a collaborative, brief, behavioral consultation intervention targeting misuse of prescribed opioids in older HIV+ adults. The intervention, CHOACOT (Consultation for HIV+ Older Adults on Chronic Opioid Therapy), will consist of:

  1. three meetings between the Behavioral Health Specialist (BHS) and the patient
  2. two brief consultations between the BHC and the HIV-PCP
  3. a joint meeting of the patient, BHC, and HIV-PCP.

To achieve our aims, we will develop CHOACOT beginning with an iterative open trial (n=10). Next, we will conduct a pilot randomized clinical trial (n=30) of CHOACOT versus enhanced Treatment-As-Usual. Opioid misuse will be the primary outcome variable. Quality of the patient-provider relationship, pain, problematic use of other substances, antiretroviral adherence, and psychosocial functioning will be secondary outcomes. The specific aims are:

Aim 1. Develop and refine CHOACOT so that it meets standards of feasibility and acceptability for HIV PCPs, BHCs, and participants;

1a. To develop and field test a CHOACOT BHC manual;

1b. To develop a reliable measure of BHC manual adherence;

1c. To develop and field-test BHC training and supervision procedures. Aim 2. Refine research procedures (e.g., consent and randomization processes, assessment procedures), and establish their feasibility and acceptability to participants while confirming recruitment goal targets.

Misuse of prescribed opioids is the primary outcome. Secondary outcomes are problematic use of substances with a high potential for lethality when used with COT (benzodiazepines, cocaine, alcohol, heroin), ARV adherence, viral load, pain, psychosocial functioning, patient-provider alliance, and treatment satisfaction and acceptability.

This line of work could lead to the incorporation into HIV care of a theoretically-driven and empirically-tested brief intervention for older HIV patients who are prescribed opioids for chronic pain and for whom there is concern about opioid misuse.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain
Actual Study Start Date : May 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
Participants in this arm will receive the study intervention (sessions with the BHC and the PCP).
Behavioral: Choacot: Behavioral Intervention for Chronic Opioid Use
This is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP.

Placebo Comparator: Health Education
Participants in this arm will receive study sessions about various health topics.
Other: Health Education



Primary Outcome Measures :
  1. opioid use [ Time Frame: 4 months ]
    opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period


Secondary Outcome Measures :
  1. quality of the patient-provider relationship [ Time Frame: 4 months ]
    quality of the patient-provider relationship will be assessed, through self-report measures, monthly over the course of the 4-month study participation period

  2. pain [ Time Frame: 4 months ]
    pain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period

  3. problematic use of other substances [ Time Frame: 4 months ]
    problematic use of other substances will be assessed, through self-report measures, monthly over the course of the 4-month study participation period

  4. antiretroviral adherence [ Time Frame: 4 months ]
    antiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period

  5. psychosocial functioning [ Time Frame: 4 months ]
    psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV patients with a physician at the enrollment site;
  • Age 50 or older;
  • Chronic pain (pain duration for at least six months);
  • Daily use of an opioid analgesic, prescribed by an HIV-PCP at the study site, for at least the past 90 days;
  • Patients endorse "feeling at risk of losing their pain medication prescription," or that they are "unhappy with how they and their doctors are working together to manage their pain";
  • Patient-rated Addictions Behavior Checklist score > 3, as a recommended cut-point indicating opioid misuse.

Exclusion Criteria:

  • Current, severe psychiatric symptoms requiring immediate clinical attention;
  • Inability to understand English;
  • Cognitive impairment severe enough to interfere with ability to actively participate in CHOACOT.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272829


Locations
Layout table for location information
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Investigators
Layout table for investigator information
Principal Investigator: Michael Stein, MD Butler Hospital

Layout table for additonal information
Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT02272829    
Other Study ID Numbers: DA038203
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents