Citicoline Treatment of Methamphetamine Dependence

NCT00950352 | Completed Phase 3 Results DMC

• 2 other identifiers: 32808CDP-1212
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methamphetamine Dependence

Keywords

methamphetamine; Citicoline; CDP-Choline; Neuroimaging; MRI; Brain; MRS; DTI

Outcome Measures

Primary Outcomes (1)

• Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo

  Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.

  8 weeks, assessed twice weekly starting week1

Secondary Outcomes (3)

• Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance.

  Neuropsychological testing will occur at week 0 and week 8/9

• Testing if Neuroimaging Measures Will Show Significant Improvements in Brain Chemical and Structural Parameters After 8-9 Weeks of Citicoline Treatment in Methamphetamine Dependent Subjects.

  Neuroimaging will occur at week 0 and week 8/9

• Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use.

  Throughout the course of the study

Study Arms (2)

Citicoline

EXPERIMENTAL

In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks.

Drug: Citicoline

Placebo

PLACEBO COMPARATOR

In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks.

Drug: Placebo

Interventions

Citicoline DRUG

Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.

Also known as: CDP-Choline

Citicoline

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• Significant medical, neurological, or psychiatric disorders

Sponsors & Collaborators

• Perry Renshaw: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Brain Institute of the University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Links

• The Brain Institute
• NIDA

MeSH Terms

Interventions

Cytidine Diphosphate Choline

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Perry Renshaw, MD, PhD, MBA
• Organization: The Brain Institute of the University of Utah

perry.renshaw@hsc.utah.edu

801-587-1216

Study Officials

• Perry F Renshaw, MD, PhD, MBA

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 31, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 11, 2015
• Results First Posted: February 11, 2015

Record last verified: 2015-02

Locations

US (1)