Opioid Use DisorderNCT05262725
Behavioral Activation for Opioid Use Disorder
A study testing Values-based Behavioral Activation in people with Opioid Use Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
The overall purpose of this pilot study is to evaluate the feasibility and acceptability of values-based behavioral activation (BA) as an adjunct intervention for patients receiving medications for opioid use disorder (OUD) in primary care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Values-based Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 23 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Diagnosis of opioid use disorder.
- Have an active prescription for buprenorphine-naloxone (Suboxone) for at least one month.
- Patient at Broadway Family Medicine (BFM)
Who cannot join
- Concurrent individual psychotherapy with a psychologist or counselor at least monthly
- Active suicidal ideation (intention, plan, or attempt in the past 30 days, as determined by chart review)
- Dementia, developmental disabilities, or cognitive functioning that is too low to participate in therapy, as determined by chart review
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Pilot Study of Behavioral Activation for People With Opioid Use Disorder
The overall purpose of this pilot study is to evaluate the feasibility and acceptability of values-based behavioral activation (BA) as an adjunct intervention for patients receiving medications for opioid use disorder (OUD) in primary care. Researcher will evaluate the following aims: 1) examine the feasibility of BA for OUD in primary care, 2) examine whether the BA intervention and study requirements are acceptable to participants, and 3) determine the psychometric properties of the outcome measures in people with OUD. Participants will complete 4-6 brief counseling sessions over the course of 12 weeks. During the first session, participants will discuss values and recovery outcomes important to them. Next, they will set 2-3 personal goals to work on before the next BA session. At the follow-up sessions, participants will update the counselor on progress made or challenges experienced. Personal values will be reviewed and participant goals updated. Study measures (surveys and urine drug tests) will be completed at the start, partway through, and at the end of the intervention.
- Conditions
- Opioid Use Disorder
- Being tested
- Values-based Behavioral Activation
- Keywords
- opioid use disorder, behavioral activation, primary care, buprenorphine
- 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.
Values-based Behavioral ActivationBehavioural
Initially, patients complete a values assessment in which they identify personal values in various life domains. With the assistance of a clinician, patients set incremental behavior goals to move their daily actions to better align with their self-reported values. Goal completion allows the patient to achieve outcomes consistent with recovery, and they potentially experience enjoyment, self-efficacy, and confidence as they progress through the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Values-based Behavioral Activation (BA) | Experimental | Not described Receives: Behavioral: Values-based Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment
% of patients approached who consent
Measured: 3 months from baseline
Recruitment Pace
Average # of patients enrolled per week
Measured: 3 months following intervention
Retention Percent
% of consented patients who complete the study
Measured: 3 months following intervention
Treatment Satisfaction
Average satisfaction score
Measured: 3 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start30 Mar 2022
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm, pre/post pilot trial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Levy, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262725
- Sponsor's protocol ID
- FMCH-2022-30580
- Status last verified
- Mar 2023
- First submitted
- 10 Feb 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hooker SA, Kim H, Lonergan-Cullum M, Busch AM, Nissly T, Levy R. Adapting behavioral activation for patients receiving medications for opioid use disorder in primary care: a pilot study. Front Psychol. 2024 Oct 8;15:1439946. doi: 10.3389/fpsyg.2024.1439946. eCollection 2024.
PubMed 39439755
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Behavioral Activation for People With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05262725
- Acronym / sponsor ID
- FMCH-2022-30580
- Conditions
- Opioid Use Disorder
- Keywords
- opioid use disorder, behavioral activation, primary care, buprenorphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- 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.
The overall purpose of this pilot study is to evaluate the feasibility and acceptability of values-based behavioral activation (BA) as an adjunct intervention for patients receiving medications for opioid use disorder (OUD) in primary care. Researcher will evaluate the following aims: 1) examine the feasibility of BA for OUD in primary care, 2) examine whether the BA intervention and study requirements are acceptable to participants, and 3) determine the psychometric properties of the outcome measures in people with OUD. Participants will complete 4-6 brief counseling sessions over the course of 12 weeks. During the first session, participants will discuss values and recovery outcomes important to them. Next, they will set 2-3 personal goals to work on before the next BA session. At the follow-up sessions, participants will update the counselor on progress made or challenges experienced. Personal values will be reviewed and participant goals updated. Study measures (surveys and urine drug tests) will be completed at the start, partway through, and at the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm, pre/post pilot trial
| Arm | Type | Receives |
|---|---|---|
| Values-based Behavioral Activation (BA) | Experimental | Behavioral: Values-based Behavioral Activation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age.
- Diagnosis of opioid use disorder.
- Have an active prescription for buprenorphine-naloxone (Suboxone) for at least one month.
- Patient at Broadway Family Medicine (BFM)
Key exclusion criteria (3 listed)
- Concurrent individual psychotherapy with a psychologist or counselor at least monthly
- Active suicidal ideation (intention, plan, or attempt in the past 30 days, as determined by chart review)
- Dementia, developmental disabilities, or cognitive functioning that is too low to participate in therapy, as determined by chart review
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 |
|---|---|---|
| Values-based Behavioral ActivationInitially, patients complete a values assessment in which they identify personal values in various life domains. With the assistance of a clinician, patients set incremental behavior goals to move their daily actions to better align with their self-reported values. Goal completion allows the patient to achieve outcomes consistent with recovery, and they potentially experience enjoyment, self-efficacy, and confidence as they progress through the treatment. | Behavioural | Values-based Behavioral Activation (BA) |
Primary outcome
Feasibility of Recruitment
Time frame: 3 months from baseline
% of patients approached who consent
Recruitment Pace
Time frame: 3 months following intervention
Average # of patients enrolled per week
Retention Percent
Time frame: 3 months following intervention
% of consented patients who complete the study
Treatment Satisfaction
Time frame: 3 months following intervention
Average satisfaction score
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 17 Mar 2023.
- Derived from this study: PubMed 39439755Hooker SA, Kim H, Lonergan-Cullum M, Busch AM, Nissly T, Levy R. Adapting behavioral activation for patients receiving medications for opioid use disorder in primary care: a pilot study. Front Psychol. 2024 Oct 8;15:1439946. doi: 10.3389/fpsyg.2024.1439946. eCollection 2024.
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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.
Robert Levy, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Values-based Behavioral Activation in people with Opioid Use Disorder, run by University of Minnesota 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 4 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 17 Mar 2023. 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. 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?
Feasibility of Recruitment (time frame: 3 months from baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05262725, which also lists 1 linked publication.
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 17 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.