Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain

NCT02272829 | Completed DMC

• 1 other identifier: DA038203
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Misuse; Older Adults; HIV

Outcome Measures

Primary Outcomes (1)

• opioid use

  opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period

  4 months

Secondary Outcomes (5)

• quality of the patient-provider relationship

  4 months

• pain

  4 months

• problematic use of other substances

  4 months

• antiretroviral adherence

  4 months

• psychosocial functioning

  4 months

Study Arms (2)

Active

ACTIVE COMPARATOR

Participants in this arm will receive the study intervention (sessions with the BHC and the PCP).

Behavioral: Choacot: Behavioral Intervention for Chronic Opioid Use

Health Education

PLACEBO COMPARATOR

Participants in this arm will receive study sessions about various health topics.

Other: Health Education

Interventions

Choacot: Behavioral Intervention for Chronic Opioid Use BEHAVIORAL

This is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP.

Active

Health Education OTHER

Health Education

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael Stein, MD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 23, 2014
• Study Start: May 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

US (1)