Opioid MisuseCHOACOTNCT02272829
Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain
A study testing Choacot: Behavioral Intervention for Chronic Opioid Use and Health Education in people with Opioid Misuse and Older Adults, run by Butler Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Opioid Misuse, Older Adults, HIV
- What is being tested?
- Choacot: Behavioral Intervention for Chronic Opioid Use and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- Opioid Misuse, Older Adults, HIV
- Being tested
- Choacot: Behavioral Intervention for Chronic Opioid Use, Health Education
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choacot: Behavioral Intervention for Chronic Opioid UseBehavioural
This is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP.
Health EducationOther
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Participants in this arm will receive the study intervention (sessions with the BHC and the PCP). Receives: Behavioral: Choacot: Behavioral Intervention for Chronic Opioid Use |
| Health Education | Placebo comparator | Participants in this arm will receive study sessions about various health topics. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid use
opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Measured: 4 months
Secondary outcomes (5)
quality of the patient-provider relationship
quality of the patient-provider relationship will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Measured: 4 months
pain
pain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Measured: 4 months
problematic use of other substances
problematic use of other substances will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Measured: 4 months
antiretroviral adherence
antiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Measured: 4 months
psychosocial functioning
psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startMay 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid MisuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
- Investigators
- Michael Stein, MD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272829
- Sponsor's protocol ID
- DA038203
- Acronym
- CHOACOT
- Status last verified
- Sep 2017
- First submitted
- 21 Oct 2014
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain
- ClinicalTrials.gov ID
- NCT02272829
- Acronym / sponsor ID
- CHOACOT / DA038203
- Conditions
- Opioid Misuse, Older Adults, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Behavioral: Choacot: Behavioral Intervention for Chronic Opioid UseParticipants in this arm will receive the study intervention (sessions with the BHC and the PCP). |
| Health Education | Placebo comparator | Other: Health EducationParticipants in this arm will receive study sessions about various health topics. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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";
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choacot: Behavioral Intervention for Chronic Opioid UseThis is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP. | Behavioural | Active |
| Health Education | Other | Health Education |
Primary outcome
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
5 secondary outcomes
quality of the patient-provider relationship
Time frame: 4 months
pain
Time frame: 4 months
problematic use of other substances
Time frame: 4 months
antiretroviral adherence
Time frame: 4 months
psychosocial functioning
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
Related trials for Opioid Misuse
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Active, not recruiting
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Chronic Pain, Opioid Use Disorder
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Stein, MD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choacot: Behavioral Intervention for Chronic Opioid Use and Health Education in people with Opioid Misuse and Older Adults, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid use (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.