Opioid-use DisorderNCT06359340

Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder

A study testing Psychosocial treatment in people with Opioid-use Disorder, run by Public Health Management Corporation at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid-use Disorder
What is being tested?: Psychosocial treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 440 participants
Where: 1 siteUnited States
Study dates: 13 Mar 2020to 31 Oct 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Adults (≥18 years)
Meet DSM 5 criteria for moderate to severe OUD;
Be deemed eligible for buprenorphine treatment for OUD by the FQHC treatment provider and agree to engage in this treatment;
Not require an inpatient level of care as determined by the healthcare provider;
Be capable of providing valid contact information and informed consent; and
Permit the research team to use and disclose their protected health information (PHI).

Who cannot join

Individuals who are intoxicated, cognitively impaired, or psychiatrically unstable at baseline will not be included; however, they may subsequently be included if the disqualifying condition subsides.
DSM 5 criteria for OUD include:
Taking opioids in larger amounts or longer than intended;
Failed efforts to quit or cut back;
Spending a lot of time obtaining the opioid;
Craving or urges to use;

Show all 13Show fewer

Repeated inability to carry out major work, school, or home obligations;
Continued use despite persistent or recurring interpersonal problems worsened by opioid use;
Stopping or reducing important social, recreational activities due to opioid use;
Recurrent use of opioids in physically hazardous situations;
Continued opioid use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance;
Tolerance; and
Withdrawal. Moderate OUD severity is denoted by the presence of 4 or 5 of these symptoms and severe OUD is denoted by 6 or more symptoms. Patients will be excluded from the study if their SUD is primarily for a different substance, or their co-morbid psychiatric needs indicate enhanced needs.

Trial locations and contacts

1 site in 1 country.

United States1 site

Philadelphia College of Osteopathic Medicine
Philadelphia, Pennsylvania, 19131

Other trials in United States

About this study

Official title: Identifying Optimal Psychosocial Interventions for Patients Receiving Office-Based Buprenorphine

Current clinical guidelines for medication assisted treatment (MAT) of opioid use disorder (OUD) recommend that treatment include a psychosocial component to help address psychological factors related to addiction. However, a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients. This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment (OBOT) with buprenorphine, which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD. The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the "one-size-fits-all" strategies that are typically used to treat OUD. Importantly, the investigators arrived at this goal, in part, through collaboration and consultation with former patients who have received different types of treatments for OUD. In this manner, patients provided important insight to inform the selection of interventions to be evaluated, patient characteristics that may differentially impact the effects of the interventions, and the patient outcomes to be examined.

Read the detailed description

The study will evaluate the comparative effectiveness of two psychosocial approaches, Cognitive Behavioral Therapy and peer support through the use of Certified Recovery Specialists provided within the context of office-based buprenorphine treatment. Patients will be randomly assigned to receive either (1) standard Medication Management (MM) as typically provided at the site, (2) MM with office-based CBT, (3) MM with CRS, and (4) MM with both CBT and CRS. In MM, patients will be seen by providers at least weekly until stable, and stabilized patients will then be seen by the provider on a monthly basis. If a patient needs a higher level of care, they will be referred to appropriate specialty treatment to ensure their safety. In the CBT study arms, CBT will be provided through 12 individual manualized sessions scheduled to coincide with patients' MM appointments when possible. As outlined by the National Institute on Drug Abuse (NIDA), sessions will cover standard CBT topics and include exercises and homework. Meta-analyses and reviews have concluded that CBT is an effective treatment across a range of SUDs and has helped to enhance treatment retention, improve medication adherence, and address ancillary problems. In the CRS study arms, CRS's will meet with clients following their first OBOT session to assist them in accessing community resources and overcoming treatment barriers, and provide ongoing patient navigation services to promote attendance at OBOT appointments. These appointments will occur either in-person or over the phone and all meetings will be tracked by the CRS. Studies indicate that peer-delivered services for individuals with mental health disorders are effective in engaging "difficult-to-reach" individuals and improving multidimensional outcomes. In the combined CBT/CRS study arm, clients will receive the individual CBT sessions and be assigned to a CRS.

Conditions: Opioid-use Disorder
Being tested: Psychosocial treatment
Keywords: Opioid Use, Buprenorphine, Psychosocial Treatment, Medication Assisted Treatment, Cognitive Behavioral Therapy, Peer Support, Opioid Use Disorder
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.

Psychosocial treatmentBehavioural
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.

Study groups in NCT06359340
Study group	Role	What they receive
MAT- OBOT	Active comparator	Those randomized to MAT standard of care will continue to receive standard office-based buprenorphine treatment. Receives: Behavioral: Psychosocial treatment
MAT+ office-based CBT	Active comparator	Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT. Receives: Behavioral: Psychosocial treatment
MAT+ CRS/Peer Support Specialist	Active comparator	Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with a CRS. Receives: Behavioral: Psychosocial treatment
MAT+ both CBT and CRS/Peer Support Specialist	Active comparator	Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT and a CRS. Receives: Behavioral: Psychosocial treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in urinalysis-confirmed opioid use from baseline through one year post-study entry
Participants will provide a urine specimen at baseline and 3, 6, 9, and 12-month assessments. Investigators will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Measured: At baseline and 3,6,9, 12-month assessments

Secondary outcomes (7)

Days Retained in Office-Based Buprenorphine Treatment
Information from the electronic health record (EHR) will be used to determine the number of days of engagement in OBOT. Investigators will obtain data from the EHR reflecting OBOT-related data including appointments attended, prescription refill information, and service dates. A patient will be identified as having dropped out of OBOT when 30 days without current buprenorphine prescription or 30 days without meeting with provider have passed.
Measured: Through 12 months
Changes in quality of life assessment: Short Form-36 (SF-36) from baseline through one year post-study entry
Quality of life will be measured using the Short Form-36 (SF-36). The SF-36 is a self-report inventory that assesses eight dimensions of physical and mental health-related quality of life. The SF-36 has been shown to have high reliability and validity. For each subscale, scores may range from 0 to 100 with higher scores reflecting greater quality of life.
Measured: At baseline and 3,6,9, 12-month assessments
Changes in multidimensional problem severity from baseline through one year post-study entry
Multidimensional problem severity, a secondary outcome, will be measured using the Addiction Severity Index-Lite (ASI-Lite). The ASI-Lite is a reliable and valid multidimensional assessment that provides composite scores reflecting current problem severity in the medical, employment, alcohol, drug, legal, family/social, and psychiatric areas. Scores may range from 0 to 1 with higher scores indicating greater problem severity.
Measured: At baseline and 3,6,9, 12-month assessments
Changes in the percentage of individuals engaging in urinalysis-confirmed use of other (non-opioid) drugs from baseline to one year post-study entry
Results from the CLIAwaived® 14-panel test and fentanyl strip described above for the primary outcome will be used as an indicator of this outcome. A binary variable reflecting other drug use versus no other drug use will be generated for this outcome.
Measured: At baseline and 3,6,9, 12-month assessments
Changes in ED utilization from baseline to one year post-study entry
The ASI-Lite (see above) captures the number of ED visits that the patient experienced during the given timeframe (i.e., past 90 days).
Measured: At baseline and 3,6,9, 12-month assessments
Changes in opioid overdose rates
The ASI-Lite (see above) captures the number of opioid overdoses that a patient experienced during the given timeframe (i.e., past 90 days). In addition, opioid overdoses will be extracted from the patient's clinical record.
Measured: At baseline and 3,6,9, 12-month assessments
Changes in treatment satisfaction from baseline to one year post-study entry
Treatment satisfaction will be measured using a subscale from the Client Satisfaction Questionnaire-8 (19). The CSQ-8 measures patient therapeutic engagement in and satisfaction with treatment. Scores may range from 8 to 32 with higher scores indicating greater treatment satisfaction.
Measured: At baseline and 3,6,9, 12-month assessments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 202031 Oct 2026

First posted11 Apr 2024
Study start13 Mar 2020
Primary completion30 May 2025
Study completion31 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)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: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 440 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06359340
Sponsor's protocol ID: OBOT-2018C2-13158
Status last verified: Jul 2025
First submitted: 2 Mar 2020
Last updated: 6 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kampman K, Jarvis M. American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. J Addict Med. 2015 Sep-Oct;9(5):358-67. doi: 10.1097/ADM.0000000000000166.
PubMed 26406300
Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2004. Report No.: (SMA) 04-3939. Available from http://www.ncbi.nlm.nih.gov/books/NBK64245/
PubMed 22514846
Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK143185/
PubMed 23762965
Dugosh K, Abraham A, Seymour B, McLoyd K, Chalk M, Festinger D. A Systematic Review on the Use of Psychosocial Interventions in Conjunction With Medications for the Treatment of Opioid Addiction. J Addict Med. 2016 Mar-Apr;10(2):93-103. doi: 10.1097/ADM.0000000000000193.
PubMed 26808307
Schwartz RP. When Added to Opioid Agonist Treatment, Psychosocial Interventions do not Further Reduce the Use of Illicit Opioids: A Comment on Dugosh et al. J Addict Med. 2016 Jul-Aug;10(4):283-5. doi: 10.1097/ADM.0000000000000236.
PubMed 27471920
Department of Health and Human Services. Medication assisted treatment for opioid use disorder (42 CFR Part 8, RIN 0930-AA22). Rockville, MD: Substance Abuse and Mental Health Services Administration.
Fiellin DA, Moore BA, Sullivan LE, Becker WC, Pantalon MV, Chawarski MC, Barry DT, O'Connor PG, Schottenfeld RS. Long-term treatment with buprenorphine/naloxone in primary care: results at 2-5 years. Am J Addict. 2008 Mar-Apr;17(2):116-20. doi: 10.1080/10550490701860971.
PubMed 18393054
Alford DP, LaBelle CT, Kretsch N, Bergeron A, Winter M, Botticelli M, Samet JH. Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Arch Intern Med. 2011 Mar 14;171(5):425-31. doi: 10.1001/archinternmed.2010.541.
PubMed 21403039
Haddad MS, Zelenev A, Altice FL. Integrating buprenorphine maintenance therapy into federally qualified health centers: real-world substance abuse treatment outcomes. Drug Alcohol Depend. 2013 Jul 1;131(1-2):127-35. doi: 10.1016/j.drugalcdep.2012.12.008. Epub 2013 Jan 17.
PubMed 23332439
Dutra L, Stathopoulou G, Basden SL, Leyro TM, Powers MB, Otto MW. A meta-analytic review of psychosocial interventions for substance use disorders. Am J Psychiatry. 2008 Feb;165(2):179-87. doi: 10.1176/appi.ajp.2007.06111851. Epub 2008 Jan 15.
PubMed 18198270
Amato L, Minozzi S, Davoli M, Vecchi S. Psychosocial and pharmacological treatments versus pharmacological treatments for opioid detoxification. Cochrane Database of Systematic Reviews; 2011. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/21901695. Accessed September 6, 2018.
McHugh RK, Hearon BA, Otto MW. Cognitive behavioral therapy for substance use disorders. Psychiatr Clin North Am. 2010 Sep;33(3):511-25. doi: 10.1016/j.psc.2010.04.012.
PubMed 20599130
Moore BA, Barry DT, Sullivan LE, O'connor PG, Cutter CJ, Schottenfeld RS, Fiellin DA. Counseling and directly observed medication for primary care buprenorphine maintenance: a pilot study. J Addict Med. 2012 Sep;6(3):205-11. doi: 10.1097/ADM.0b013e3182596492.
PubMed 22614936
Fiellin DA, Barry DT, Sullivan LE, Cutter CJ, Moore BA, O'Connor PG, Schottenfeld RS. A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine. Am J Med. 2013 Jan;126(1):74.e11-7. doi: 10.1016/j.amjmed.2012.07.005.
PubMed 23260506
Ling W, Hillhouse M, Ang A, Jenkins J, Fahey J. Comparison of behavioral treatment conditions in buprenorphine maintenance. Addiction. 2013 Oct;108(10):1788-98. doi: 10.1111/add.12266. Epub 2013 Jul 12.
PubMed 23734858

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Identifying Optimal Psychosocial Interventions for Patients Receiving Office-Based Buprenorphine
ClinicalTrials.gov ID: NCT06359340
Acronym / sponsor ID: OBOT-2018C2-13158
Conditions: Opioid-use Disorder
Keywords: Opioid Use, Buprenorphine, Psychosocial Treatment, Medication Assisted Treatment, Cognitive Behavioral Therapy, Peer Support, Opioid Use Disorder
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 440 participants (estimated)
Lead sponsor: Public Health Management CorporationUniversity, hospital or other
Collaborators: Boston University, Patient-Centered Outcomes Research Institute, Philadelphia College of Osteopathic Medicine, University of Pennsylvania
Study start: 13 Mar 2020 (actual)
Primary completion: 30 May 2025 (actual)
Study completion: 31 Oct 2026 (estimated)
First posted: 11 Apr 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
MAT- OBOT	Active comparator	Behavioral: Psychosocial treatmentThose randomized to MAT standard of care will continue to receive standard office-based buprenorphine treatment.
MAT+ office-based CBT	Active comparator	Behavioral: Psychosocial treatmentThose randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT.
MAT+ CRS/Peer Support Specialist	Active comparator	Behavioral: Psychosocial treatmentThose randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with a CRS.
MAT+ both CBT and CRS/Peer Support Specialist	Active comparator	Behavioral: Psychosocial treatmentThose randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT and a CRS.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adults (≥18 years)
Meet DSM 5 criteria for moderate to severe OUD;
Be deemed eligible for buprenorphine treatment for OUD by the FQHC treatment provider and agree to engage in this treatment;
Not require an inpatient level of care as determined by the healthcare provider;
Be capable of providing valid contact information and informed consent; and

Key exclusion criteria (13 listed)

Individuals who are intoxicated, cognitively impaired, or psychiatrically unstable at baseline will not be included; however, they may subsequently be included if the disqualifying condition subsides.
Taking opioids in larger amounts or longer than intended;
Failed efforts to quit or cut back;
Spending a lot of time obtaining the opioid;
Craving or urges to use;

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
Psychosocial treatmentParticipants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.	Behavioural	MAT+ CRS/Peer Support Specialist, MAT+ both CBT and CRS/Peer Support Specialist, MAT+ office-based CBT, MAT- OBOT

Primary outcome

Changes in urinalysis-confirmed opioid use from baseline through one year post-study entry
Time frame: At baseline and 3,6,9, 12-month assessments
Participants will provide a urine specimen at baseline and 3, 6, 9, and 12-month assessments. Investigators will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.

7 secondary outcomes

Days Retained in Office-Based Buprenorphine Treatment
Time frame: Through 12 months
Changes in quality of life assessment: Short Form-36 (SF-36) from baseline through one year post-study entry
Time frame: At baseline and 3,6,9, 12-month assessments
Changes in multidimensional problem severity from baseline through one year post-study entry
Time frame: At baseline and 3,6,9, 12-month assessments
Changes in the percentage of individuals engaging in urinalysis-confirmed use of other (non-opioid) drugs from baseline to one year post-study entry
Time frame: At baseline and 3,6,9, 12-month assessments
Changes in ED utilization from baseline to one year post-study entry
Time frame: At baseline and 3,6,9, 12-month assessments
Changes in opioid overdose rates
Time frame: At baseline and 3,6,9, 12-month assessments
Changes in treatment satisfaction from baseline to one year post-study entry
Time frame: At baseline and 3,6,9, 12-month assessments

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
Background: PubMed 26406300Kampman K, Jarvis M. American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. J Addict Med. 2015 Sep-Oct;9(5):358-67. doi: 10.1097/ADM.0000000000000166.
Background: PubMed 22514846Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2004. Report No.: (SMA) 04-3939. Available from http://www.ncbi.nlm.nih.gov/books/NBK64245/
Background: PubMed 23762965Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK143185/
Background: PubMed 26808307Dugosh K, Abraham A, Seymour B, McLoyd K, Chalk M, Festinger D. A Systematic Review on the Use of Psychosocial Interventions in Conjunction With Medications for the Treatment of Opioid Addiction. J Addict Med. 2016 Mar-Apr;10(2):93-103. doi: 10.1097/ADM.0000000000000193.
Background: PubMed 27471920Schwartz RP. When Added to Opioid Agonist Treatment, Psychosocial Interventions do not Further Reduce the Use of Illicit Opioids: A Comment on Dugosh et al. J Addict Med. 2016 Jul-Aug;10(4):283-5. doi: 10.1097/ADM.0000000000000236.
BackgroundDepartment of Health and Human Services. Medication assisted treatment for opioid use disorder (42 CFR Part 8, RIN 0930-AA22). Rockville, MD: Substance Abuse and Mental Health Services Administration.
Background: PubMed 18393054Fiellin DA, Moore BA, Sullivan LE, Becker WC, Pantalon MV, Chawarski MC, Barry DT, O'Connor PG, Schottenfeld RS. Long-term treatment with buprenorphine/naloxone in primary care: results at 2-5 years. Am J Addict. 2008 Mar-Apr;17(2):116-20. doi: 10.1080/10550490701860971.
Background: PubMed 21403039Alford DP, LaBelle CT, Kretsch N, Bergeron A, Winter M, Botticelli M, Samet JH. Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Arch Intern Med. 2011 Mar 14;171(5):425-31. doi: 10.1001/archinternmed.2010.541.
Background: PubMed 23332439Haddad MS, Zelenev A, Altice FL. Integrating buprenorphine maintenance therapy into federally qualified health centers: real-world substance abuse treatment outcomes. Drug Alcohol Depend. 2013 Jul 1;131(1-2):127-35. doi: 10.1016/j.drugalcdep.2012.12.008. Epub 2013 Jan 17.
Background: PubMed 18198270Dutra L, Stathopoulou G, Basden SL, Leyro TM, Powers MB, Otto MW. A meta-analytic review of psychosocial interventions for substance use disorders. Am J Psychiatry. 2008 Feb;165(2):179-87. doi: 10.1176/appi.ajp.2007.06111851. Epub 2008 Jan 15.
BackgroundAmato L, Minozzi S, Davoli M, Vecchi S. Psychosocial and pharmacological treatments versus pharmacological treatments for opioid detoxification. Cochrane Database of Systematic Reviews; 2011. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/21901695. Accessed September 6, 2018.
Background: PubMed 20599130McHugh RK, Hearon BA, Otto MW. Cognitive behavioral therapy for substance use disorders. Psychiatr Clin North Am. 2010 Sep;33(3):511-25. doi: 10.1016/j.psc.2010.04.012.
Individual participant dataSharing planned: No

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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.

David S Festinger, Ph.D. principal investigator

Philadelphia College of Osteopathic Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Psychosocial treatment in people with Opioid-use Disorder, run by Public Health Management Corporation 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 13 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Changes in urinalysis-confirmed opioid use from baseline through one year post-study entry (time frame: At baseline and 3,6,9, 12-month assessments). 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 NCT06359340, which also lists 21 linked publications.

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 6 Aug 2025.