NCT00158249

Brief Summary

The Three Aims of this study are (only studies for Aim 1 were completed)

  1. 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.
  2. 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.
  3. 3.Measure the effects of citicoline on marijuana-induced cue-induced craving and brain electrical activity (EEG).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4 years until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
21 days until next milestone

Results Posted

Study results publicly available

October 22, 2014

Completed
Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

3.3 years

First QC Date

September 8, 2005

Results QC Date

October 15, 2014

Last Update Submit

October 15, 2014

Conditions

Marijuana Abuse

Keywords

citicoline, drug abuse, marijuana

Outcome Measures

Primary Outcomes (1)

  • Marijuana Use

    Measured for 8 weeks of treatment

Secondary Outcomes (1)

  • Neurocognitive Function

    Before and after 8 weeks of treatment

Study Arms (2)

placebo

PLACEBO COMPARATOR

matched capsules

Drug: placebo

citicoline

EXPERIMENTAL

2 gm/day

Drug: citicoline

Interventions

citicolineDRUG

2 gm/day, 8 weeks treatment

citicoline
placeboDRUG

matched for physical appearance

placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Meets DSM-IV criteria for current marijuana dependence
  • Women with a negative pregnancy test prior to study entry
  • Heavy smoker, defined as smoking more than 10 joints per week

You may not qualify if:

  • Abnormal electrocardiogram (ECG)
  • Medical disorder that requires prescription medication
  • Psychiatric disorder that requires prescription medication
  • Abnormal liver function tests
  • Taking herbal preparations
  • Taking any over-the-counter medications on a chronic basis
  • Pregnancy or breast feeding
  • Neurological, infectious, or neoplastic disease
  • Currently seeking treatment for marijuana abuse
  • Meets criteria for alcohol, cocaine, or opioid dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital, Department of Psychiatry

Belmont, Massachusetts, 02478 9106, United States

Location

Related Publications (1)

  • Bracken BK, Penetar DM, Rodolico J, Ryan ET, Lukas SE. Eight weeks of citicoline treatment does not perturb sleep/wake cycles in cocaine-dependent adults. Pharmacol Biochem Behav. 2011 Jun;98(4):518-24. doi: 10.1016/j.pbb.2011.03.003. Epub 2011 Mar 21.

    PMID: 21397626DERIVED

MeSH Terms

Conditions

Marijuana AbuseSubstance-Related Disorders

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsCytidine DiphosphateCytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Results Point of Contact

Title
Scott E. Lukas, Ph.D.
Organization
McLean Hospital
slukas@mclean.harvard.edu
617-855-2767

Study Officials

  • Scott E. Lukas, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, MIC & BPRL

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2009

Primary Completion

January 1, 2013

Study Completion

October 1, 2014

Last Updated

October 22, 2014

Results First Posted

October 22, 2014

Record last verified: 2014-10

Locations

US(1)