CDP-choline Treatment in ATS Users

Ewha Womans University

Status and phase: Enrolling; Phase 2

Conditions: Substance Use Disorders

Treatments: Drug: Placebo; Drug: CDP-choline; Behavioral: Supportive psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02630069

NIH_ATS

Details and patient eligibility

About

This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 14 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 3 patient groups, including a placebo group

CDP-choline+supportive psychotherapy

Experimental group

Description:

CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks

Treatment:

Behavioral: Supportive psychotherapy

Drug: CDP-choline

Placebo+supportive psychotherapy

Placebo Comparator group

Description:

Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks

Treatment:

Behavioral: Supportive psychotherapy

Drug: Placebo

Healthy control

No Intervention group

Description:

No intervention