NCT00368550

Brief Summary

The purpose of this study is to determine whether Sertraline, compared to placebo, is effective in the treatment of alcohol dependence as a function of the subtype of alcoholic patient being treated. This involved administering sertraline (to a maximum of 200 mg/day) or an inactive placebo for a 14-week treatment period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_4

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, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 31, 2010

Completed
Last Updated

June 21, 2011

Status Verified

June 1, 2011

Enrollment Period

5.3 years

First QC Date

August 22, 2006

Results QC Date

June 4, 2010

Last Update Submit

June 17, 2011

Conditions

Alcoholism

Keywords

Alcohol DrinkingAlcohol DependenceSertraline PharmacotherapyAlcoholism SubtypesEarly- versus Late-Onset Alcoholism

Outcome Measures

Primary Outcomes (1)

  • Number of Days on Which Subjects Drank

    Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.

    12-week treatment period

Secondary Outcomes (2)

  • Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)

    12-week treatment period

  • Change in the Level of Alcohol-related Problems

    12-week treatment period compared with baseline value

Study Arms (2)

1

EXPERIMENTAL

Oral sertraline, cognitive-behavioral counseling to maintain abstinence from alcohol

Drug: Sertraline

2

PLACEBO COMPARATOR

Placebo, cognitive-behavioral counseling to maintain abstinence from alcohol

Drug: Placebo

Interventions

SertralineDRUG

Sertraline (to a maximum of 200 mg/day) for 14-week treatment period

Also known as: Zoloft
1
PlaceboDRUG

Placebo for 14-week treatment period

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current episode (i.e., in the preceding month) of alcohol dependence defined by Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) criteria
  • years of age
  • Abstinent from alcohol for a period of at least 3 days prior to baseline research assessment
  • Able to read English and complete study evaluations
  • Male, or if female, without active reproductive potential
  • Participants will have signed informed consent

You may not qualify if:

  • Currently meets criteria for dependence on a psychoactive substance other than alcohol and nicotine
  • Regular use of psychoactive drugs including anxiolytics and antidepressants
  • Current use of disulfiram or naltrexone
  • Current major depression or psychosis (or other severe psychiatric disability e.g., suicidality, current mania)
  • Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac pathology, which in the opinion of the evaluating physician would preclude the patient from study adherence or be of potential harm to the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (2)

  • Kranzler HR, Armeli S, Tennen H, Covault J. 5-HTTLPR genotype and daily negative mood moderate the effects of sertraline on drinking intensity. Addict Biol. 2013 Nov;18(6):1024-31. doi: 10.1111/adb.12007. Epub 2012 Nov 12.

    PMID: 23145795DERIVED

  • Kranzler HR, Armeli S, Tennen H. Post-treatment outcomes in a double-blind, randomized trial of sertraline for alcohol dependence. Alcohol Clin Exp Res. 2012 Apr;36(4):739-44. doi: 10.1111/j.1530-0277.2011.01659.x. Epub 2011 Oct 7.

    PMID: 21981418DERIVED

MeSH Terms

Conditions

AlcoholismAlcohol Drinking

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Henry R. Kranzler, M.D.
Organization
University of Pennsylvania
kranzler_h@mail.trc.upenn.edu
215-222-3200

Study Officials

  • Henry R. Kranzler, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 24, 2006

Study Start

February 1, 2004

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

June 21, 2011

Results First Posted

August 31, 2010

Record last verified: 2011-06

Locations

US(1)