Citicoline Treatment of Methamphetamine Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Perry Renshaw, University of Utah
ClinicalTrials.gov Identifier:
NCT00950352
First received: July 29, 2009
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

The purpose of the study is to determine if citicoline (a nutritional supplement) is effective in helping people reduce their dependence on methamphetamine. The investigators will use neuroimaging to look at the structure and chemical make up of the brain at the start of the study and after 8-9 weeks of treatment of citicoline or placebo.


Condition Intervention Phase
Methamphetamine Dependence
Drug: Citicoline
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Citicoline Treatment of Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Methamphetamine dependent subjects treated with citicoline will show significantly reduced use of methamphetamine as well as use of other drugs (caffeine, nicotine, alcohol, cocaine and marijuana) compared to the placebo treated group. [ Time Frame: each week starting week 1 through week 8 ] [ Designated as safety issue: No ]
  • Citicoline will significantly reduce drop-out compared to placebo during the waiting period for clinical treatment. [ Time Frame: weeks 1-10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Citicoline administration will be associated with significant improvements in neuropsychological performance, especially in measurement of attention and verbal memory in the MA group. [ Time Frame: Neuropsychological testing will occur at week 0 and week 8/9 ] [ Designated as safety issue: No ]
  • Neuroimaging measures will show significant improvements in brain chemical and structural parameters (an increase of NAA levels, cortical thickness, and increased FA values) after 8-9 weeks of citicoline treatment in methamphetamine dependent subjects. [ Time Frame: Neuroimaging will occur at week 0 and week 8/9 ] [ Designated as safety issue: No ]
  • Improvements in cognitive function as well as brain chemical and structural parameters will be associated with greater reductions in drug use. [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: No ]
    Self report drug use and mood will be evaluated at each study visit throughout the course of the study. Also, urine samples will be collected twice a week for drugs of abuse testing.


Enrollment: 104
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Citicoline
In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks.
Drug: Citicoline
Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.
Other Name: CDP-Choline
Placebo Comparator: Placebo
In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks.
Drug: Placebo
Subjects will be given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.

Detailed Description:

This is a prospective, randomized, double-blind, placebo-controlled study, in which we will systematically evaluate the therapeutic effects of citicoline, which may both increase dopamine and normalize cognitive and structural deficits in the brains of methamphetamine dependent subjects. Methamphetamine dependent subjects will undergo baseline and repeat cognitive assessments after 8-9 weeks of placebo or oral citicoline as a nutritional supplement. We will also evaluate the chemical and structural changes in brain regions identified by magnetic resonance spectroscopy (MRS), diffusion tension imaging (DTI) and cortical thickness, which in turn are expected to recover after 8-9 weeks of citicoline treatment. Specific brain regions of interest include the prefrontal cortices, temporal cortex, and the caudate/putamen all of which are known to be involved in the pathophysiology of methamphetamine dependence.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Methamphetamine Dependent Subject Eligibility:

Inclusion Criteria:

  • Subjects who use methamphetamine as their preferred drug of abuse.
  • Subjects must be between the ages of 18 and 45 years.
  • Subjects must have recent methamphetamine use (within 6 months of screening).
  • Subjects must have an established residence and phone.
  • Subjects must be able to give informed consent.

Exclusion Criteria:

  • Significant current or past medical, neurological, or psychiatric co-morbidity including cardiovascular, renal, and endocrine disorder, as identified by medical history.
  • Pregnant subjects - due to the unknown effects of MRI on a fetus. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded. Female subjects who are of child-bearing potential will have to pass a urine pregnancy test before each visit.
  • Subjects who, in the investigator's judgment, pose a current serious homicidal or suicidal risk.
  • Subjects who will not likely be able to comply with the study protocol.
  • Subjects who have any contraindication to an MR scan.
  • Hypersensitivity to any of the study drugs or excipients
  • Subjects with current DSM-IV diagnosis of a major mental illness. Major illness will be defined as Major Depression, Manic Depression, Schizophrenia, Dissociative Disorder, other psychotic illnesses, Attention-Deficit Hyperactivity Disorder, Post Traumatic Stress Disorder, Borderline Personality Disorder, Reactive Attachment Disorder, and Panic Disorder.
  • Predominant alcohol or other substance dependence as preferred drug of abuse.
  • Positive HIV test result.
  • An individual having any pending legal or criminal charge or action, or who has pending or a reasonable potential for court involvement, or a person who is incarcerated or is in detention, or who is pending or having completed a competency evaluation or commitment procedure.

Healthy Control Subject Eligibility:

Inclusion Criteria:

  • Subjects must be between the ages of 18 and 45 years.
  • Subjects must be able to give informed consent.
  • To have an established residence and phone.

Exclusion Criteria:

  • Significant medical, neurological, or psychiatric disorders
  • Pregnant subjects - due to the unknown effects of MRI on a fetus. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded. Female subjects who are of child-bearing potential will have to pass a urine pregnancy test before each visit.
  • Subjects who have any contraindication to an MR scan.
  • Subjects unable to comply with protocol.
  • Positive HIV test result.
  • Positive urine drug screen.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950352

Locations
United States, Utah
The Brain Institute of the University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Perry Renshaw
Investigators
Principal Investigator: Perry F Renshaw, MD, PhD, MBA University of Utah
  More Information

Additional Information:
NIDA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Perry Renshaw, Professor of Psychiatry, University of Utah
ClinicalTrials.gov Identifier: NCT00950352     History of Changes
Other Study ID Numbers: 32808, CDP-1212
Study First Received: July 29, 2009
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
methamphetamine
Citicoline
CDP-Choline
Neuroimaging
MRI
Brain
MRS
DTI

Additional relevant MeSH terms:
Choline
Cytidine Diphosphate Choline
Methamphetamine
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Central Nervous System Stimulants
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014