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Completed

NCT Number: NCT03580902

CBT4CBT for Office Based Buprenorphine

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).

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Central Medical Unit of the APT Foundation

New Haven, Connecticut, 06511-5991, United States

About this study

In this phase, 100 individuals entering buprenorphine maintenance at the primary care clinic (Central Medical Unit, CMU) will be randomized to either (1) standard buprenorphine maintenance in which counseling is offered on site, or (2) standard buprenorphine maintenance with CBT4CBT-Buprenorphine substituting for on-site counseling. This will be a 12-week trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

CBT4CBT-Buprenorphine

Behavioral

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

buprenorphine/naloxone

Drug

Standard outpatient buprenorphine maintenance

Primary outcomes

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

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

CBT4CBT, LLC

Industry

Registry information

Official study title

A Method to Increase Buprenorphine Treatment Capacity

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 10, 2018
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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