NCT03580902

Brief Summary

In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a larger and diverse population of individuals seeking buprenorphine treatment in primary care (N=100).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 25, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 22, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

June 25, 2018

Last Update Submit

January 2, 2023

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

  • Percent of urine toxicology screens that are negative for opioids by group.

    Percent of urine toxicology screens, collected weekly, that are negative for opioid metabolites.

    12 weeks

Study Arms (2)

Standard Buprenorphine

ACTIVE COMPARATOR

Participants assigned to this arm will received buprenorphine treatment consistent with standard practice at the study site. This includes induction by a physician, regular meetings with a physician for medical management, urine monitoring, and prescription of buprenorphine, with access to behavioral support services.

Drug: Buprenorphine/naloxone

Standard Buprenorphine plus CBT4CBT-Buprenorphine

EXPERIMENTAL

Participants in this condition will receive Standard Buprenorphine as described above, with the addition of access to the CBT4CBT-Buprenorphine program, which is a web-based program that covers basic knowledge about buprenorphine treatment as well as teaches cognitive and behavioral coping skills.

Behavioral: CBT4CBT-BuprenorphineDrug: Buprenorphine/naloxone

Interventions

CBT4CBT-BuprenorphineBEHAVIORAL

Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment

Standard Buprenorphine plus CBT4CBT-Buprenorphine
Buprenorphine/naloxoneDRUG

Standard outpatient buprenorphine maintenance

Standard BuprenorphineStandard Buprenorphine plus CBT4CBT-Buprenorphine

Eligibility Criteria

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

You may qualify if:

  • Meets current Diagnostic Statistical Manual (DSM-5) criteria for opioid use disorder
  • Requesting buprenorphine maintenance treatment at Central Medical Unit of the APT Foundation

You may not qualify if:

  • Unstabilized psychotic disorder
  • Currently suicidal or homicidal
  • Current cocaine, benzodiazepine, or alcohol use disorder.
  • Any history of PCP (phencyclidine) use.
  • Pregnant or lactating
  • Any other physical or mental condition that would contraindicate office-based buprenorphine maintenance treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Medical Unit of the APT Foundation

New Haven, Connecticut, 06511-5991, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Julia Shi, MD

    APT Foundation, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 10, 2018

Study Start

January 22, 2019

Primary Completion

November 23, 2021

Study Completion

August 1, 2022

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)