Lamotrigine for Ketamine Dependence Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to investigate the efficacy of lamotrigine in the treatment of ketamine dependence in a double-blind, placebo controlled design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFebruary 1, 2018
January 1, 2018
1.7 years
September 8, 2015
January 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urine drug screen
Negative result of urinary drug toxicology screen of ketamine
12 weeks
Secondary Outcomes (2)
subjective visual analogue scales of craving
12 weeks
Retention rate
12 weeks
Study Arms (2)
lamotrigine
EXPERIMENTALlamotrigine extended release up to 200 mg/day,
Placebo
PLACEBO COMPARATORIdentical Placebo
Interventions
Starting from 25 mg/day in the first week, then titrated up to 200 mg/day for 12 weeks
Same dosing schedule as study drug
Eligibility Criteria
You may qualify if:
- Current users of ketamine, including having a ketamine-positive urine
- Meeting DSM-5 criteria for ketamine use disorder
- Age between 18 to 65 years old
- Women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study.
You may not qualify if:
- Significant medical conditions such as abnormal liver function or renal function confirmed by laboratory tests
- Hypertension
- A current cardiac condition or high risk of cardiovascular disease
- Seizure disorders
- Any another significant underlying medical condition which would contraindicate lamotrigine treatment
- Meeting DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders
- Meeting DSM-IV psychiatric classifications for substance use disorder other than ketamine within three month except tobacco or caffeine.
- Exhibiting current suicidality or homicidality
- Pregnant women, lactating women or women who are planning to be pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei City Hospitallead
- Chang Gung Memorial Hospitalcollaborator
Study Sites (1)
Taipei City Hospital and Psychiatric Center
Taipei, 110, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shih-Ku Lin, MD
Taipei City Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair of Department of Psychiatry
Study Record Dates
First Submitted
September 8, 2015
First Posted
September 22, 2015
Study Start
September 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
February 1, 2018
Record last verified: 2018-01