Substance Use Disorders
Conditions
Keywords
amphetamine type stimulant, adolescents
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.
Interventions
DRUGCDP-choline
CDP-choline 500mg once a day for 12 weeks
DRUGPlacebo
Placebo 500mg once a day for 12 weeks
BEHAVIORALSupportive psychotherapy
Supportive psychotherapy 1 session/2 weeks for 12 weeks
Sponsors
Ewha Womans University Mokdong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 40 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening | baseline through 12 weeks |
| abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples | baseline through 12 weeks |
| treatment program retention | baseline through 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| functional brain changes in magnetic resonance imaging assessed by computational approaches | baseline and 12 weeks |
| standardized scores on a neuropsychological test battery | baseline and 12 weeks |
| metabolic brain changes in magnetic resonance imaging assessed by computational approaches | baseline and 12 weeks |
| number of participants with adverse events | baseline through 12 weeks |
| structural brain changes in magnetic resonance imaging assessed by computational approaches | baseline and 12 weeks |
Countries
South Korea
Contacts
Primary ContactSujung Yoon, MD, PhD
Outcome results
None listed