Opioid-use DisorderNCT03367234
Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings
A study testing Individual Therapy Sessions, Cognitive Behavioral Therapy (CBT) and Medication-Assisted Treatment in people with Opioid-use Disorder and Substance Use Disorders, run by Public Health Management Corporation.
Trial summary
This study evaluates the effectiveness of integrating empirically-supported treatments for an opioid use disorder into a primary care setting. These treatments will include ASAM Criteria multidimensional assessment, cognitive behavioral therapy and relapse prevention with contingency management, medication-assisted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Substance Use Disorders
- What is being tested?
- Individual Therapy Sessions, Cognitive Behavioral Therapy (CBT) and Medication-Assisted Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to 30 Jun 2022
- 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
- Patient is 18 years or older
- As determined according to the ASAM Criteria CONTINUUM Software decision engine, patient meets criteria for: a) Level 1 care, i.e., outpatient treatment, OR b) Level 2 care, i.e., intensive outpatient treatment.
Who cannot join
- The medical practitioner or BHC overrule these criteria because medical and psychiatric complications exist that would contraindicate research participation
- Patient requires an ASAM level of care greater than Level 2
- The patient reports plans to leave the area (i.e. Philadelphia or Washington, DC greater metropolitan area) within the next 6 months
- The patient is not English-speaking
- The patient is unable to provide valid informed consent by correctly describing the key components of consent to the Research Assistant.
About this study
Official title: A Simple Large Trial of Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings
This study evaluates the effectiveness of integrating empirically-supported treatments for an opioid use disorder into a primary care setting. These treatments will include ASAM Criteria multidimensional assessment, cognitive behavioral therapy and relapse prevention with contingency management, medication-assisted treatment, and recovery support services. Half of participants will be assigned to opioid use disorder treatment in a federally qualified health center, and half will receive treatment at a publicly-funded intensive outpatient addiction treatment program which has the ability to offer medication-assisted treatment.
Read the detailed description
This is a large, simple, comparative effectiveness trial of the Personalized Addiction Treatment-to-Health Model vs. standard care in the community specialty addiction treatment system. PATH combines several empirically supported treatment methods in a flexible schedule in tandem with primary care, with the goals of higher rates of confirmed substance abstinence and treatment retention.
PATH components include: 1) The CONTINUUM multidimensional assessment, an evidence-based implementation of the American Society of Addiction Medicine (ASAM) placement criteria; 2) Cognitive Behavioral Relapse Prevention (CB/RP), a skills-based approach centered on teaching coping skills to handle risky situations that can be practiced and learned; 3) Contingency management (CM), which targets chronic substance use's diminution of brain dopaminergic reward by specifically conditioning positive recovery behaviors via immediate financial incentives; and 4) Recovery Support Services, non-professional community-based services for wrap-around care needs.
Effect sizes for a combined CB/RP and CM approach appear to be large and there is evidence that this combination results in longer lasting improvements presumably as homeostasis returns to the reward system. An extensive literature demonstrates that counseling plus medication-assisted treatment (MAT) yields superior outcomes versus counseling alone. Buprenorphine and extended-release naltrexone are well suited for use in primary care. Buprenorphine is a partial agonist at the mu-opioid receptor that provides anti-withdrawal and anti-craving effects for up to 36 hours on a single dose. Partial agonism and a slow onset diminish the patient's perception of euphoria, limiting abuse, while the long half-life and binding duration make it useful for both detoxification and long-term opioid maintenance. Extended-release naltrexone is a once-monthly intramuscular injection that, following detoxification, provides opioid receptor blockade for at least 30 days and is safe and effective for prolonging abstinence and preventing relapse from opiates.
- Conditions
- Opioid-use Disorder, Substance Use Disorders
- Being tested
- Individual Therapy Sessions, Cognitive Behavioral Therapy (CBT), Medication-Assisted Treatment, Peer Recovery Specialist Support, Group Therapy Sessions
- Keywords
- Federally Qualified Health Center, Contingency Management, Cognitive Behavioral Therapy, Cognitive Behavioral / Relapse Prevention, Medication Assisted Treatment, Behavioral Health Consultant, Integrated Care
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Therapy SessionsBehavioural
One-on-one sessions with a counselor
Cognitive Behavioral Therapy (CBT)Behavioural
Also called CBT, CB/RP
Cognitive Behavioral Therapy techniques delivered by a behavioral health consultant (BHC)
Medication-Assisted TreatmentBehavioural
Also called MAT
Buprenorphine or Extended-Release Naltrexone
Peer Recovery Specialist SupportBehavioural
Individual and/or group sessions with a certified peer recovery specialist
Group Therapy SessionsBehavioural
Group therapy sessions
Psychiatric ConsultationBehavioural
Access to psychiatric consultation
Contingency ManagementBehavioural
Rewards for engagement in specified recovery behaviors
| Study group | Role | What they receive |
|---|---|---|
| Personalized Addiction-to-Health (PATH) | Experimental | Cognitive Behavioral Therapy (CBT) sessions with a behavioral health consultant twice weekly for weeks 1-13, once weekly for weeks 14-26, as needed weeks 27-52; Contingency management rewards for specified recovery behaviors which could include medication adherence, attendance at CB/RP sessions and/or CB/RP exercise participation; Medication-assisted treatment, either extended-release naltrexone once monthly or buprenorphine once daily; Peer recovery specialist support twice weekly for weeks 1-13, once weekly for weeks 14-26, as needed for weeks 27-52; Psychiatric consultation as needed. Receives: Behavioral: Individual Therapy Sessions; Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Medication-Assisted Treatment; Behavioral: Peer Recovery Specialist Support; Behavioral: Psychiatric Consultation; Behavioral: Contingency Management |
| Standard Care | Active comparator | Treatment may differ slightly by treatment program, but addiction specialty Intensive Outpatient Treatment (ASAM Level 2.1) will generally include individual therapy sessions with a counselor 1 hour per week for week; Medication-assisted treatment, either extended-release naltrexone once monthly or suboxone once daily; Group therapy sessions 9 hours per week then decreasing to 3 hours per week; Psychiatric consultation as needed. Receives: Behavioral: Individual Therapy Sessions; Behavioral: Medication-Assisted Treatment; Behavioral: Peer Recovery Specialist Support; Behavioral: Group Therapy Sessions; Behavioral: Psychiatric Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in confirmed substance abstinence
On-site urine drug testing kits rapidly test for cocaine, opiates, amphetamines, methamphetamines, benzodiazepines, cannabis, barbiturates, Phencyclidine, and alcohol. Urine testing will be administered at all follow-ups to capture use within the last 3 days.
Measured: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Change in retention in treatment
Verify patient self-report of treatment engagement by acquiring payment data from funders. Federally Qualified Health Centers and Standard Care Intensive Outpatient programs will release study patient records to resolve inconsistencies between patient report and billing data, including treatment session attendance, medications prescribed, prescriptions filled, doses received, and results from urinalysis testing. Data will be collected for the past 3 months.
Measured: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Secondary outcomes (3)
Lower rates of service utilization
Patient reported service utilization including substance abuse treatment, medical services, visits to medical offices, hospitalizations, and emergency room visits received that were not a part of the assigned treatment during the past 3 months
Measured: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Higher quality of life
Self-reported enjoyment and satisfaction experienced in various areas of daily functioning during the past week
Measured: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Lower rates of HIV risk behaviors
Self-reported drug use, injection-related risk behavior, sexual risk, and HIV testing history and results for the past 3 months.
Measured: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study startJul 2019 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Why it stopped: Study experienced delays due to site recruitment. Funder terminated contract.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Management Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- David R Gastfriend, MD, Principal investigator, Public Health Management Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367234
- Sponsor's protocol ID
- PCS-1605-35373
- Status last verified
- Jun 2019
- First submitted
- 28 Nov 2017
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Large Trial of Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings
- ClinicalTrials.gov ID
- NCT03367234
- Acronym / sponsor ID
- PCS-1605-35373
- Conditions
- Opioid-use Disorder, Substance Use Disorders
- Keywords
- Federally Qualified Health Center, Contingency Management, Cognitive Behavioral Therapy, Cognitive Behavioral / Relapse Prevention, Medication Assisted Treatment, Behavioral Health Consultant, Integrated Care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study experienced delays due to site recruitment. Funder terminated contract.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Public Health Management CorporationUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jul 2019 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Dec 2017 (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.
This study evaluates the effectiveness of integrating empirically-supported treatments for an opioid use disorder into a primary care setting. These treatments will include ASAM Criteria multidimensional assessment, cognitive behavioral therapy and relapse prevention with contingency management, medication-assisted treatment, and recovery support services. Half of participants will be assigned to opioid use disorder treatment in a federally qualified health center, and half will receive treatment at a publicly-funded intensive outpatient addiction treatment program which has the ability to offer medication-assisted treatment.
Detailed description
This is a large, simple, comparative effectiveness trial of the Personalized Addiction Treatment-to-Health Model vs. standard care in the community specialty addiction treatment system. PATH combines several empirically supported treatment methods in a flexible schedule in tandem with primary care, with the goals of higher rates of confirmed substance abstinence and treatment retention.
PATH components include: 1) The CONTINUUM multidimensional assessment, an evidence-based implementation of the American Society of Addiction Medicine (ASAM) placement criteria; 2) Cognitive Behavioral Relapse Prevention (CB/RP), a skills-based approach centered on teaching coping skills to handle risky situations that can be practiced and learned; 3) Contingency management (CM), which targets chronic substance use's diminution of brain dopaminergic reward by specifically conditioning positive recovery behaviors via immediate financial incentives; and 4) Recovery Support Services, non-professional community-based services for wrap-around care needs.
Effect sizes for a combined CB/RP and CM approach appear to be large and there is evidence that this combination results in longer lasting improvements presumably as homeostasis returns to the reward system. An extensive literature demonstrates that counseling plus medication-assisted treatment (MAT) yields superior outcomes versus counseling alone. Buprenorphine and extended-release naltrexone are well suited for use in primary care. Buprenorphine is a partial agonist at the mu-opioid receptor that provides anti-withdrawal and anti-craving effects for up to 36 hours on a single dose. Partial agonism and a slow onset diminish the patient's perception of euphoria, limiting abuse, while the long half-life and binding duration make it useful for both detoxification and long-term opioid maintenance. Extended-release naltrexone is a once-monthly intramuscular injection that, following detoxification, provides opioid receptor blockade for at least 30 days and is safe and effective for prolonging abstinence and preventing relapse from opiates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Addiction-to-Health (PATH) | Experimental | Behavioral: Individual Therapy Sessions, Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Medication-Assisted Treatment, Behavioral: Peer Recovery Specialist Support, Behavioral: Psychiatric Consultation, Behavioral: Contingency ManagementCognitive Behavioral Therapy (CBT) sessions with a behavioral health consultant twice weekly for weeks 1-13, once weekly for weeks 14-26, as needed weeks 27-52; Contingency management rewards for specified recovery behaviors which could include medication adherence, attendance at CB/RP sessions and/or CB/RP exercise participation; Medication-assisted treatment, either extended-release naltrexone once monthly or buprenorphine once daily; Peer recovery specialist support twice weekly for weeks 1-13, once weekly for weeks 14-26, as needed for weeks 27-52; Psychiatric consultation as needed. |
| Standard Care | Active comparator | Behavioral: Individual Therapy Sessions, Behavioral: Medication-Assisted Treatment, Behavioral: Peer Recovery Specialist Support, Behavioral: Group Therapy Sessions, Behavioral: Psychiatric ConsultationTreatment may differ slightly by treatment program, but addiction specialty Intensive Outpatient Treatment (ASAM Level 2.1) will generally include individual therapy sessions with a counselor 1 hour per week for week; Medication-assisted treatment, either extended-release naltrexone once monthly or suboxone once daily; Group therapy sessions 9 hours per week then decreasing to 3 hours per week; Psychiatric consultation as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is 18 years or older
- As determined according to the ASAM Criteria CONTINUUM Software decision engine, patient meets criteria for: a) Level 1 care, i.e., outpatient treatment, OR b) Level 2 care, i.e., intensive outpatient treatment.
Key exclusion criteria (5 listed)
- The medical practitioner or BHC overrule these criteria because medical and psychiatric complications exist that would contraindicate research participation
- Patient requires an ASAM level of care greater than Level 2
- The patient reports plans to leave the area (i.e. Philadelphia or Washington, DC greater metropolitan area) within the next 6 months
- The patient is not English-speaking
- The patient is unable to provide valid informed consent by correctly describing the key components of consent to the Research Assistant.
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 |
|---|---|---|
| Individual Therapy SessionsOne-on-one sessions with a counselor | Behavioural | Personalized Addiction-to-Health (PATH), Standard Care |
| Cognitive Behavioral Therapy (CBT)Also: CBT, CB/RPCognitive Behavioral Therapy techniques delivered by a behavioral health consultant (BHC) | Behavioural | Personalized Addiction-to-Health (PATH) |
| Medication-Assisted TreatmentAlso: MATBuprenorphine or Extended-Release Naltrexone | Behavioural | Personalized Addiction-to-Health (PATH), Standard Care |
| Peer Recovery Specialist SupportIndividual and/or group sessions with a certified peer recovery specialist | Behavioural | Personalized Addiction-to-Health (PATH), Standard Care |
| Group Therapy SessionsGroup therapy sessions | Behavioural | Standard Care |
| Psychiatric ConsultationAccess to psychiatric consultation | Behavioural | Personalized Addiction-to-Health (PATH), Standard Care |
| Contingency ManagementRewards for engagement in specified recovery behaviors | Behavioural | Personalized Addiction-to-Health (PATH) |
Primary outcome
Change in confirmed substance abstinence
Time frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
On-site urine drug testing kits rapidly test for cocaine, opiates, amphetamines, methamphetamines, benzodiazepines, cannabis, barbiturates, Phencyclidine, and alcohol. Urine testing will be administered at all follow-ups to capture use within the last 3 days.
Change in retention in treatment
Time frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Verify patient self-report of treatment engagement by acquiring payment data from funders. Federally Qualified Health Centers and Standard Care Intensive Outpatient programs will release study patient records to resolve inconsistencies between patient report and billing data, including treatment session attendance, medications prescribed, prescriptions filled, doses received, and results from urinalysis testing. Data will be collected for the past 3 months.
3 secondary outcomes
Lower rates of service utilization
Time frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Higher quality of life
Time frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Lower rates of HIV risk behaviors
Time frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- 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 R Gastfriend, MD principal investigator
Public Health Management Corporation
Questions about this trial
What is this clinical trial studying?
A study testing Individual Therapy Sessions, Cognitive Behavioral Therapy (CBT) and Medication-Assisted Treatment in people with Opioid-use Disorder and Substance Use Disorders, run by Public Health Management Corporation.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in confirmed substance abstinence (time frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups). The study lists 2 primary outcomes in all. 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 21 Jun 2019.