NCT04650386

Brief Summary

The purpose of this study is to address important knowledge gaps regarding the optimal way to provide psychosocial treatment to patients who are receiving buprenorphine for opioid use disorder (OUD) in office-based settings. The project will develop and evaluate an adaptive treatment approach in which the interventions are delivered based on the individual needs of patients at baseline and throughout the course of care. The adaptive intervention will incorporate certified recovery specialists (CRSs) and cognitive behavioral therapy (CBT), two interventions that have been widely used in the treatment of OUD. The efficacy of the adaptive intervention will be evaluated through a randomized controlled trial (RCT) that will be conducted in federally qualified health (FQHCs) in Philadelphia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

3.7 years

First QC Date

November 5, 2020

Last Update Submit

November 4, 2024

Conditions

Opioid-use Disorder

Keywords

Opioid UseMedication Assisted TreatmentPsychosocial TreatmentCognitive Behavioral TherapyPeer SupportPeer Recovery SpecialistCertified Recovery SpecialistOpioid Use DisorderAdaptive InterventionOffice-Based Opioid TreatmentBuprenorphine

Outcome Measures

Primary Outcomes (4)

  • Urinalysis-confirmed abstinence from opioids at 3 month follow up

    Participants will provide a urine specimen at the 3 month follow up assessment. We 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.

    3 months post study entry

  • Urinalysis-confirmed abstinence from opioids at 6 month follow up

    Participants will provide a urine specimen at the 6 month follow up assessment. We 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.

    6 months post study entry

  • Urinalysis-confirmed abstinence from opioids at 9 month follow up

    Participants will provide a urine specimen at the 9 month follow up assessment. We 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.

    9 months post study entry

  • Urinalysis-confirmed abstinence from opioids at 12 month follow up

    Participants will provide a urine specimen at the 12 month follow up assessment. We 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.

    12 months post study entry

Secondary Outcomes (5)

  • Abstinence from or reductions in use of other (non-opioid) psychoactive substances

    Through 12 months post-study entry

  • Retention in buprenorphine-based OBOT

    Through 12 months post-study entry

  • Quality of life assessment

    Through 12 months post-study entry

  • Psychosocial functioning/Multidimensional problem severity

    Through 12 months post-study entry

  • Treatment satisfaction

    Through 12 months post-study entry

Study Arms (2)

Treatment As Usual (TAU)

NO INTERVENTION

Participants assigned to the TAU condition will be scheduled for buprenorphine medication management appointments and will receive OBOT at the FQHC and adjunctive psychosocial treatment as typically provided at the FQHC. The team will continue to meet with the patient during subsequent MAT visits on a decreasing frequency, with some slight site-specific variation. The schedule of MAT visits generally includes 3 clinic visits during the week of induction, 1-2 visits per week until the patient is stabilized, and monthly thereafter. Behavioral health clinicians provide support to the patient, discuss UDS results, assist with strategic problem-solving around recovery and adjustment to sobriety, and monitor the patient's engagement in MAT.

Adaptive Intervention

EXPERIMENTAL

Participants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period.

Behavioral: Psychosocial support determined by adaptive treatment algorithm

Interventions

Psychosocial support determined by adaptive treatment algorithmBEHAVIORAL

Participants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period.

Adaptive Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have initiated office-based buprenorphine treatment for OUD at the FQHC within the last 4 weeks;
  • Not require an inpatient level of care as determined by the healthcare provider; and
  • Be capable of providing valid contact information and informed consent.

You may not qualify if:

  • Patient is under the age of 18;
  • Co-morbid psychiatric disorder indicating the need for more intensive residential treatment
  • Patient is unable to provide informed consent.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Project HOME Stephen J. Klein Wellness Center

Philadelphia, Pennsylvania, 19121, United States

Location

PHMC Care Clinic

Philadelphia, Pennsylvania, 19123, United States

Location

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  • Lent MR, Dugosh KL, Hurstak E, Callahan HR, Mazur K; Greater Philadelphia Opioid Use Disorder Research Group. Prevalence and predictors of suicidality among adults initiating office-based buprenorphine. Addict Sci Clin Pract. 2023 Jun 1;18(1):37. doi: 10.1186/s13722-023-00393-y.

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  • Lent MR, Gaither-Hardy D, Favor KE, Harris D, Cos TA, Millard C, Kone Z, Van Riper A, Dugosh KL. The development, implementation and early learnings of a training program to advance interest in behavioral research careers among undergraduate BIPOC students majoring in psychology. BMC Med Educ. 2023 Mar 15;23(1):160. doi: 10.1186/s12909-023-04104-8.

    PMID: 36922813DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Karen Dugosh, Ph.D.

    PHMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

December 2, 2020

Study Start

September 21, 2020

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)