Cytidine-5'-Diphosphate-choline Treatment in Amphetamine Type Stimulant-using Adolescents
Overview
- Phase
- Phase 2
- Intervention
- CDP-choline
- Conditions
- Substance Use Disorders
- Sponsor
- Ewha Womans University Mokdong Hospital
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening
- Last Updated
- 3 years ago
Overview
Brief Summary
This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.
Detailed Description
This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline (CDP-choline) in amphetamine-type stimulants-using adolescents. Multi-level assessments will be performed to determine whether CDP-choline administration with supportive psychotherapy, compared to placebo administration with supportive psychotherapy, will 1) repair ATS-induced neural cell damage of the target brain regions, 2) improve cognitive deficits and normalize the relevant target neural circuits, and then 3) reduce ATS-taking behaviors in ATS-using adolescents.
Investigators
Sujung Yoon
Professor
Ewha Womans University Mokdong Hospital
Eligibility Criteria
Inclusion Criteria
- •Aged 14-40 years
- •Amphetamine (or amphetamine-like) use disorder (DSM-IV-TR)
- •Informed consent
- •Seeking treatment
Exclusion Criteria
- •Major medical or neurological illnesses
- •Psychiatric illnesses requiring hospitalization, prescription of psychotropic medications, or emergency psychiatric interventions
- •Current and past diagnosis of a psychotic disorder, bipolar disorder, conduct disorder, or attention-deficit hyperactivity disorder
- •Occasional ATS use (less than monthly use)
- •IQ of 80 or lower
- •Pregnancy or breastfeeding
- •Clinically significant suicidal or homicidal ideation
- •Substance use disorders (substances other than amphetamine or MA)
Arms & Interventions
CDP-choline+supportive psychotherapy
CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
Intervention: CDP-choline
CDP-choline+supportive psychotherapy
CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
Intervention: Supportive psychotherapy
Placebo+supportive psychotherapy
Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
Intervention: Placebo
Placebo+supportive psychotherapy
Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
Intervention: Supportive psychotherapy
Outcomes
Primary Outcomes
the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening
Time Frame: baseline through 12 weeks
abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples
Time Frame: baseline through 12 weeks
treatment program retention
Time Frame: baseline through 12 weeks
Secondary Outcomes
- standardized scores on a neuropsychological test battery(baseline and 12 weeks)
- structural brain changes in magnetic resonance imaging assessed by computational approaches(baseline and 12 weeks)
- number of participants with adverse events(baseline through 12 weeks)
- functional brain changes in magnetic resonance imaging assessed by computational approaches(baseline and 12 weeks)
- metabolic brain changes in magnetic resonance imaging assessed by computational approaches(baseline and 12 weeks)