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Sertraline Pharmacotherapy for Alcoholism Subtypes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00368550
Recruitment Status : Completed
First Posted : August 24, 2006
Results First Posted : August 31, 2010
Last Update Posted : June 21, 2011
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
UConn Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Alcoholism
Interventions Drug: Sertraline
Drug: Placebo
Enrollment 134
Recruitment Details Recruitment from Feb. 2004 to March 2009 through advertisements and referrals by area clinicians.
Pre-assignment Details All patients underwent physical examination and routine laboratory testing during screening. 143 prospective patients were screened, of which 4 did not meet study criteria and 5 chose not to participate.
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit. Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
Period Title: Overall Study
Started 63 71
Completed 35 48
Not Completed 28 23
Reason Not Completed
Adverse Event             7             4
Lack of Efficacy             4             9
Withdrawal by Subject             17             10
Arm/Group Title Sertraline Placebo Total
Hide Arm/Group Description Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit. Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit. Total of all reporting groups
Overall Number of Baseline Participants 63 71 134
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 71 participants 134 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
62
  98.4%
71
 100.0%
133
  99.3%
>=65 years
1
   1.6%
0
   0.0%
1
   0.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 71 participants 134 participants
47.7  (10.1) 47.3  (9.5) 47.5  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 71 participants 134 participants
Female
12
  19.0%
14
  19.7%
26
  19.4%
Male
51
  81.0%
57
  80.3%
108
  80.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 63 participants 71 participants 134 participants
63 71 134
1.Primary Outcome
Title Number of Days on Which Subjects Drank
Hide Description Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.
Time Frame 12-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects with missing days imputed as drinking days.
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
Overall Number of Participants Analyzed 63 71
Mean (Standard Deviation)
Unit of Measure: days
37.0  (30.6) 33.8  (27.3)
2.Secondary Outcome
Title Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)
Hide Description Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as heavy drinking days.
Time Frame 12-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
Overall Number of Participants Analyzed 63 71
Mean (Standard Deviation)
Unit of Measure: days
31.9  (29.0) 26.4  (26.4)
3.Secondary Outcome
Title Change in the Level of Alcohol-related Problems
Hide Description Measured using the SIP (Short Inventory of Problems), which was administered at pretreatment and at the end of treatment. The range of scores on the SIP is 0 (no alcohol-related problems) to 45 (most severe alcohol-related problems) and the time frame for reporting is the preceding 3 months. The data presented here represent a difference score of treatment minus baseline.
Time Frame 12-week treatment period compared with baseline value
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description:
Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
Overall Number of Participants Analyzed 63 71
Mean (Standard Deviation)
Unit of Measure: Units on a scale
6.0  (9.2) 9.0  (9.5)
Time Frame 14 weeks
Adverse Event Reporting Description Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.
 
Arm/Group Title Sertraline Placebo
Hide Arm/Group Description Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit. Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
All-Cause Mortality
Sertraline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Sertraline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/63 (4.76%)      0/71 (0.00%)    
Cardiac disorders     
Hospitalization due to chest pain   1/63 (1.59%)  1 0/71 (0.00%)  0
Psychiatric disorders     
Hospitalization due to relapse to heavy drinking   2/63 (3.17%)  2 0/71 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sertraline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/63 (34.92%)      14/71 (19.72%)    
Gastrointestinal disorders     
nausea   7/63 (11.11%)  7 7/71 (9.86%)  7
diarrhea   16/63 (25.40%)  21 10/71 (14.08%)  13
Nervous system disorders     
tired/sleepy   13/63 (20.63%)  15 4/71 (5.63%)  4
decreased appetite   4/63 (6.35%)  4 0/71 (0.00%)  0
Psychiatric disorders     
agitation   2/63 (3.17%)  2 5/71 (7.04%)  5
insomnia   6/63 (9.52%)  6 7/71 (9.86%)  8
Reproductive system and breast disorders     
sexual problems   15/63 (23.81%)  17 3/71 (4.23%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Henry R. Kranzler, M.D.
Organization: University of Pennsylvania
Phone: 215-222-3200 ext 137
EMail: kranzler_h@mail.trc.upenn.edu
Layout table for additonal information
Responsible Party: Henry R. Kranzler, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00368550    
Other Study ID Numbers: 03-225-2
R01AA013631 ( U.S. NIH Grant/Contract )
First Submitted: August 22, 2006
First Posted: August 24, 2006
Results First Submitted: June 4, 2010
Results First Posted: August 31, 2010
Last Update Posted: June 21, 2011