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Trial record 28 of 215 for:    Lamotrigine

Lamotrigine for Ketamine Dependence Trial

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ClinicalTrials.gov Identifier: NCT02556060
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Lin, Shih-Ku, Taipei City Hospital

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.

Condition or disease Intervention/treatment Phase
Addiction Drug: Lamotrigine Drug: Placebo Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Lamotrigine for Ketamine Dependence: A Randomized, Double-Blind, Placebo-Controlled Trial
Study Start Date : September 2015
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: lamotrigine
lamotrigine extended release up to 200 mg/day,
Drug: Lamotrigine
Starting from 25 mg/day in the first week, then titrated up to 200 mg/day for 12 weeks
Other Name: Lamofree ER

Drug: Placebo
Same dosing schedule as study drug
Other Name: Identical to Lamofree ER

Placebo Comparator: Placebo
Identical Placebo
Drug: Lamotrigine
Starting from 25 mg/day in the first week, then titrated up to 200 mg/day for 12 weeks
Other Name: Lamofree ER

Drug: Placebo
Same dosing schedule as study drug
Other Name: Identical to Lamofree ER




Primary Outcome Measures :
  1. Urine drug screen [ Time Frame: 12 weeks ]
    Negative result of urinary drug toxicology screen of ketamine


Secondary Outcome Measures :
  1. subjective visual analogue scales of craving [ Time Frame: 12 weeks ]
    Scores of subjective visual analogue scales of craving rated by patient

  2. Retention rate [ Time Frame: 12 weeks ]
    Rate of patients stay in this trial



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Current users of ketamine, including having a ketamine-positive urine
  2. Meeting DSM-5 criteria for ketamine use disorder
  3. Age between 18 to 65 years old
  4. 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.

Exclusion Criteria:

  1. Significant medical conditions such as abnormal liver function or renal function confirmed by laboratory tests
  2. Hypertension
  3. A current cardiac condition or high risk of cardiovascular disease
  4. Seizure disorders
  5. Any another significant underlying medical condition which would contraindicate lamotrigine treatment
  6. Meeting DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders
  7. Meeting DSM-IV psychiatric classifications for substance use disorder other than ketamine within three month except tobacco or caffeine.
  8. Exhibiting current suicidality or homicidality
  9. Pregnant women, lactating women or women who are planning to be pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556060


Locations
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Taiwan
Taipei City Hospital and Psychiatric Center
Taipei, Taiwan, 110
Sponsors and Collaborators
Taipei City Hospital
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Shih-Ku Lin, MD Taipei City Hospital

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Responsible Party: Lin, Shih-Ku, Chair of Department of Psychiatry, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT02556060     History of Changes
Other Study ID Numbers: TCHIRB-102309
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Keywords provided by Lin, Shih-Ku, Taipei City Hospital:
ketamine use disorder
lamotrigine
craving
Additional relevant MeSH terms:
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Lamotrigine
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Ketamine
Anticonvulsants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Sodium Channel Blockers