Butler Hospital
Providence, Rhode Island, 02906, United States
NCT Number: NCT02272829
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.
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02906, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP.
Time frame: 4 months
opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
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
Time frame: 4 months
pain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
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
Time frame: 4 months
antiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Time frame: 4 months
psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Butler Hospital
Other
Acronym: CHOACOT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04941950
Chemically-Induced Disorders, Mental Disorders
Bridgeport, Connecticut, United States
View Trial DetailsNCT05182606
Chemically-Induced Disorders, Chronic Pain
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT05503186
Chemically-Induced Disorders, Mental Disorders
Winston-Salem, North Carolina, United States
View Trial DetailsNCT06554431
Chemically-Induced Disorders, Chronic Pain
The Bronx, New York, United States
View Trial Details