Substance Use Disorders Clinical Trial
Official title:
Cytidine-5'-Diphosphate-choline Treatment in Amphetamine Type Stimulant-using Adolescents
NCT number | NCT02630069 |
Other study ID # | NIH_ATS |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | December 2022 |
This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 40 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Ewha Womans University Mokdong Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Ewha Womans University Mokdong Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening | baseline through 12 weeks | ||
Primary | abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples | baseline through 12 weeks | ||
Primary | treatment program retention | baseline through 12 weeks | ||
Secondary | standardized scores on a neuropsychological test battery | baseline and 12 weeks | ||
Secondary | number of participants with adverse events | baseline through 12 weeks | ||
Secondary | structural brain changes in magnetic resonance imaging assessed by computational approaches | baseline and 12 weeks | ||
Secondary | functional brain changes in magnetic resonance imaging assessed by computational approaches | baseline and 12 weeks | ||
Secondary | metabolic brain changes in magnetic resonance imaging assessed by computational approaches | baseline and 12 weeks |
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