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NCT00158249 · ClinicalTrials.gov registry record · Phase 2

Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals

A Phase 2 study, sponsored by Mclean Hospital.

Completed
Registry status
Phase 2
Development phase
21
Enrollment target

NCT00158249 is a Phase 2 study that has completed, run by Mclean Hospital. The registered enrollment target is 21 participants.

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The verdict

NCT00158249, a Phase 2 study, has completed, sponsored by Mclean Hospital.

COMPLETED
Registry status
Phase 2
Development phase
21 participants
Enrollment target

Study Summary

The Three Aims of this study are (only studies for Aim 1 were completed) 1. Measure the impact of citicoline on marihuana use patterns in subjects' individualized natural settings and responses to marihuana challenge using functional brain MRI scans. Hypothesis - 2 g/day citicoline will produce greater reductions in marihuana use and craving in heavy marihuana users than placebo citicoline over a 8-week treatment period as measured in their natural environments. The same participants will experience greater improved brain activation patterns and an improvement in cognitive functioning compared to placebo controlled subjects. 2. Measure the effects of citicoline on marihuana absorption and metabolism and determine if these changes parallel changes in subjective and physiological responses in a laboratory setting. Hypothesis - Chronic (8 weeks) treatment with 2 g/day citicoline will produce increases in subjective and physiological effects of both acute marihuana smoking and placebo marihuana smoking compared to chronic placebo citicoline. Citicoline will have no effect on marihuana pharmacokinetics. 3. Measure the effects of citicoline on marijuana-induced cue-induced craving and brain electrical activity (EEG). Hypothesis - Chronic (8 weeks) treatment with 2 g/day citicoline will reduce objective measures of marijuana cue-reactivity, and subjective reports of craving in response to marihuana cues will also be attenuated compared to chronic placebo citicoline treatment.

Interventions

  • DRUG placebo
  • DRUG citicoline

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2009-09
Est. Completion 2014-10
Phase Phase 2

Sponsor

Mclean Hospital

140 total trials

What the Registry Record Tells You About NCT00158249

The ClinicalTrials.gov registry entry for NCT00158249 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00158249 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00158249 about?

NCT00158249 is a clinical study titled "Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals". The Three Aims of this study are (only studies for Aim 1 were completed) 1. Measure the impact of citicoline on marihuana use patterns in subjects' individualized natural settings and responses to marihuana challenge using functional brain MRI scans. Hypothesis - 2 g/day citicoline will produce...

What is the current status of trial NCT00158249?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2009-09. Estimated completion is 2014-10.

What interventions are being tested in trial NCT00158249?

The interventions under investigation include: placebo (DRUG), citicoline (DRUG).

Who is sponsoring clinical trial NCT00158249?

This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.