NCT00249405

Brief Summary

This study is being done to determine if citalopram is safe and effective in the treatment of alcohol dependence. A second purpose is to evaluate whether alcohol dependent individuals who differ in a specific genetic marker respond differently to citalopram. Citalopram is a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of depression. It belongs to a category of medications called selective serotonin re-uptake inhibitors or SSRIs. The U.S. FDA has not approved citalopram for the treatment of alcohol dependence. Therefore, it is being used "off-label" in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2005

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

Study Start

First participant enrolled

February 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 3, 2010

Status Verified

November 1, 2010

Enrollment Period

5.7 years

First QC Date

November 4, 2005

Last Update Submit

November 2, 2010

Conditions

AlcoholismAlcohol Abuse

Keywords

Clinical trialAlcoholismAlcoholPharmacogeneticsCitalopramGenotypeTherapy complianceSerotonin inhibitorAlcoholism/alcohol abuse therapy

Outcome Measures

Primary Outcomes (1)

  • Percent days abstinent

    24 weeks

Secondary Outcomes (1)

  • Percent heavy drinking days

    24 weeks

Study Arms (2)

1

EXPERIMENTAL

citalopram

Drug: Citalopram + MI

2

PLACEBO COMPARATOR

Placebo

Behavioral: Placebo + MI

Interventions

Citalopram + MIDRUG

14-week citalopram treatment + Motivational Interview (MI) and 9 brief sessions of a manual-guided Compliance Enhancement Therapy; post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks.

Also known as: celexa
1
Placebo + MIBEHAVIORAL

placebo + single Motivational Interview (MI) and 9 brief sessions of a manual-guided Compliance Enhancement Therapy; post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks.

2

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients with a diagnosis of DSM-IV alcohol dependence
  • Not morbidly obese or underweight
  • Express desire to quit or cut down on drinking for duration of trial

You may not qualify if:

  • Clinically significant laboratory evidence of diseases
  • Have active psychological disorders other than alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45237, United States

Location

Related Publications (2)

  • Thompson RD, Heffner JL, Strong JA, Blom TJ, Anthenelli RM. Relationship between the serotonin transporter polymorphism and obsessive-compulsive alcohol craving in alcohol-dependent adults: a pilot study. Alcohol. 2010 Aug;44(5):401-6. doi: 10.1016/j.alcohol.2010.05.008. Epub 2010 Jul 3.

    PMID: 20598843DERIVED

  • Heffner JL, Tran GQ, Johnson CS, Barrett SW, Blom TJ, Thompson RD, Anthenelli RM. Combining motivational interviewing with compliance enhancement therapy (MI-CET): development and preliminary evaluation of a new, manual-guided psychosocial adjunct to alcohol-dependence pharmacotherapy. J Stud Alcohol Drugs. 2010 Jan;71(1):61-70. doi: 10.15288/jsad.2010.71.61.

    PMID: 20105415DERIVED

MeSH Terms

Conditions

AlcoholismPatient Compliance

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Robert M. Anthenelli, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 7, 2005

Study Start

February 1, 2005

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 3, 2010

Record last verified: 2010-11

Locations

US(1)