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
|Condition or disease||Intervention/treatment||Phase|
|Opioid Misuse Older Adults HIV||Behavioral: Choacot: Behavioral Intervention for Chronic Opioid Use Other: Health Education||Not Applicable|
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:
- three meetings between the Behavioral Health Specialist (BHS) and the patient
- two brief consultations between the BHC and the HIV-PCP
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- pain [ Time Frame: 4 months ]pain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
- 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
- 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
- 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
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
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Michael Stein, MD||Butler Hospital|