Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Dis… (NCT06434818) | Clinical Trial Compass
RecruitingPhase 2
Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
United States300 participantsStarted 2023-07-07
Plain-language summary
The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 18 - 80 years, inclusive at enrollment.
✓. Diagnosis of current moderate or severe substance use disorders, opioid use disorders, stimulant (cocaine and methamphetamine) use, and alcohol use disorders in the past three months, including the past month.
✓. Does not meet criteria for other current SUDs outside of the 3 above, except for mild or moderate use of cannabis
✓. Willing to receive study interventions and buprenorphine (for OUD group) and naltrexone (for AUD group) during the study
✓. Females must not be pregnant at enrollment and agree not to become pregnant during the trial, through scientifically valid ways of contraception
✓. Willing to sign the informed consent form.
✓. Have a stable place to stay and retain the EDITOR devices in a secure condition when receiving the intervention and during the entire duration of the study participation.
Exclusion criteria
✕. Any significant neurological disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy, or seizures.
✕. Presence of serious mental illness, such as schizophrenia, bipolar disorders, and suicidal risk. Diagnosis of major depressive disorders, anxiety disorders, and post-traumatic stress disorders (PTSD), will be included if symptoms are stable, with no suicidal ideas or plans, and there are no recent changes in treatment of these conditions in the 6 weeks prior to enrollment.
✕. Experiencing current suicide ideas or plans.
✕. Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, or liver cirrhosis as determined by the site PI.
✕. History of severe traumatic nose injury that affects the ability to smell or significant intranasal disease, as determined by the site PI.
✕. Known allergies or intolerance to aromas from plant essential oils. E.g., orange and lemon.
✕. Breastfeeding or pregnancy test positive or plans to get pregnant in the 6 months following enrollment.