CBT4CBT for Office Based Buprenorphine

CBT4CBT

Status and phase: Completed; Phase 2; Phase 1

Conditions: Opioid-use Disorder

Treatments: Drug: Buprenorphine/naloxone; Behavioral: CBT4CBT-Buprenorphine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03580902

41941

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Standard Buprenorphine

Active Comparator group

Description:

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.

Treatment:

Drug: Buprenorphine/naloxone

Standard Buprenorphine plus CBT4CBT-Buprenorphine

Experimental group

Description:

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.

Treatment:

Behavioral: CBT4CBT-Buprenorphine

Drug: Buprenorphine/naloxone