Opioid-use Disorder
Conditions
Brief summary
To conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving CBT4CBT-Buprenorphine + Recovery Coach in a population of 60 individuals who meet current DSM criteria for opioid use disorder and are receiving buprenorphine treatment in primary care.
Detailed description
In this pilot study, 50 individuals with OUD on buprenorphine will be randomized to either 1) standard of care (N=25) or (2)CBT4CBT-Buprenorphine + Recovery Coach (N=250). This will be an 8-week trial.
Interventions
BEHAVIORALCBT4CBT-Buprenorphine + Recovery Coach
This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professionalCBT4CBT-Buprenorphine is an 8-session (module) system for teaching a wide range of CBT skills (understanding and changing patterns of substance use; coping with craving; refusing offers of drugs and alcohol; problem-solving skills; identifying and changing thoughts about drugs and alcohol; and improving decision-making skills)
Sponsors
Clemson University
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adults (≥18 years) * having a DSM-V diagnosis of OUD * sublingual buprenorphine/naloxone and/or buprenorphine * having initiated maintenance treatment for OUD for at least 30 days before the screening * self-report or toxicology screening positive for any substance within 30 days of screening; * willing to accept a random assignment to either TAU/CBT4CBT-Buprenorphine + Recovery Coach; * having adequate computer skills
Exclusion criteria
* having a severe medical or psychiatric disability that could impair their ability to perform study-related activities (determined by the clinician) * being pregnant or breastfeeding; * being unable to independently read and/or comprehend the consent form or other study materials * being unable to read/speak English; * having current suicidal ideation based on the Patient Health Questionnaire-9.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in drug use | 0-8 weeks | Using saliva toxicology tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention to buprenorphine | 3 month follow up | enrollment in and receiving buprenorphine and/or other effective medication treatment for OUD which will be verified by either report from the treatment clinic or electronic medical record |
| Change in drug use | 1 and 3 month follow up | Using saliva toxicology tests |
Other
| Measure | Time frame | Description |
|---|---|---|
| Commission errors | 0-8 weeks | This score indicates the number of times e client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. |
| Selective attention | 0-8 weeks | This outcome will be measured by the Stroop Color and Word Test. This Stroop Test has three parts that generate simple and complex reaction times. Averaging the two complex reaction time scores from the Stroop Test generates a domain score for reaction time. |
| Cognitive performance through Electroencephalogram | 0-8 weeks | This outcome will be measured by alpha, the dominant frequency in the human scalp EEG of adults. |
Countries
United States
Outcome results
None listed