Clinical trial NCT02630069: CDP-choline Treatment in ATS Users
Official title: Cytidine-5'-Diphosphate-choline Treatment in Amphetamine Type Stimulant-using Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Substance Use Disorders
Keywords: amphetamine type stimulant
adolescents
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening
timeFrame: baseline through 12 weeks
measure: abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples
timeFrame: baseline through 12 weeks
measure: treatment program retention
timeFrame: baseline through 12 weeks
Secondary outcomes:
measure: standardized scores on a neuropsychological test battery
timeFrame: baseline and 12 weeks
measure: number of participants with adverse events
timeFrame: baseline through 12 weeks
measure: structural brain changes in magnetic resonance imaging assessed by computational approaches
timeFrame: baseline and 12 weeks
measure: functional brain changes in magnetic resonance imaging assessed by computational approaches
timeFrame: baseline and 12 weeks
measure: metabolic brain changes in magnetic resonance imaging assessed by computational approaches
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
References: