Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Topiramate Treatment of Problem Drinkers

This study has been completed.
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Henry Kranzler, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00626925
First received: February 21, 2008
Last updated: August 2, 2016
Last verified: August 2016
Results First Received: April 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Alcohol Drinking
Interventions: Drug: topiramate
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was initiated at the University of Connecticut Health Center in March 2008 and was transferred to the University of Pennsylvania in December 2010. The last study visit was completed on 11/20/2013. We enrolled a total of 200 subjects, randomizing 138 to study medication. We recruited participants using flyers, newspaper and radio ads.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active Med

topiramate (up to 200 mg orally)

topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)

Placebo

placebo

placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)


Participant Flow:   Overall Study
    Active Med   Placebo
STARTED   67   71 
COMPLETED   55   62 
NOT COMPLETED   12   9 
Lost to Follow-up                1                2 
relapse                1                0 
Adverse effect                6                2 
Lack of Efficacy                1                4 
Time constraints                3                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
In the Total topiramate and Placebo group e included all subjects enrolled who were randomized into the study based.

Reporting Groups
  Description
Total Topiramate Group

topiramate (up to 200 mg orally)

topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)

Total Placebo Group

placebo

placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)

Total Total of all reporting groups

Baseline Measures
   Total Topiramate Group   Total Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   71   138 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 49.3  (9)   52.8  (7.4)   51.07  (8.3) 
[1] Enrollment was open to participants age 18 to 65 years old
Gender 
[Units: Participants]
     
Female   22   30   52 
Male   45   41   86 
Race (NIH/OMB) [1] 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   1   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   10   4   14 
White   56   66   122 
More than one race   0   0   0 
Unknown or Not Reported   1   0   1 
[1] We collect information about race from participants
Proportion Heavy drinking Days preceding screening visit [1] 
[Units: Proportion Heavy drinking days]
Mean (Standard Deviation)
 .67  (.27)   .66  (.27)   .66  (.27) 
[1] Proportion of Heavy drinking Days, 90 days preceding the screening visit
Location of enrollment [1] 
[Units: Participants]
     
University Of Connecticut   39   37   76 
University of Pennsylvania   28   34   62 
[1] Connecticut subjects were enrolled at the University of Connecticut and Philadelphia subjects at the University of Pennsylvania.
Education [1] 
[Units: Years]
Mean (Standard Deviation)
 15.8  (2.5)   15.3  (2.5)   15.5  (2.5) 
[1] Level of Education measured in years of education.
Marital Status [1] 
[Units: Number of participants]
     
Married   39   45   84 
Not married   28   26   54 
[1] Total number married
Annual Income [1] 
[Units: Participants]
     
Less than $40,000   6   9   15 
$40,000–$79,999   14   15   29 
$80,000 –$119,000   18   19   37 
$120,000 or more   28   28   56 
Missing   1   0   1 
[1] Annual income measured in categorical amounts
Beck Depression Inventory score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.1  (4.8)   6.8  (5.3)   6.48  (5.07) 
[1] Total Beck Depression Inventory score The Beck Depression Inventory (BDI), a 21-item self-report measure of depressive symptoms, yields a total score that ranges from 0 to 63, higher scores indicating higher depression (Beck et al. 1961). The BDI is generally regarded as a sensitive self-report measure of depressive symptoms, and will be used to explore the relation between depressive symptoms and response to medication and counseling.
Proportion of abstinent days [1] 
[Units: Proportion of abstinent days]
Mean (Standard Deviation)
 0.13  (0.16)   0.12  (0.15)   0.12  (0.15) 
[1] Proportion of abstinent days, 90 days preceding the screening visit.
Short Index of Problems [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 14.9  (8.6)   15.5  (6.7)   15.20  (7.6) 
[1] The Short Inventory of Problems (SIP). The SIP, a 15-item instrument, yields a total score that ranges from 0 to 45, higher score worse outcomes. The SIP was derived from the Drinker Inventory of Consequences (DrInC), which was developed for use in Project MATCH (Miller and Tonigan 1995). We (Feinn et al. 2003) have found that, like the DrInC, the SIP measures a single factor of alcohol-related problems. Given that it is substantially shorter than the DrInC, we will use the SIP as a measure of alcohol-related consequences.
Lifetime major depression (M.D.) [1] 
[Units: # of participants]
     
Lifetime episode Major Depression   18   22   40 
No lifetime Major Depression episode   49   49   98 
[1] Lifetime episode of major depression based on a Structured Clinical Interview for DSM-IV (SCID-I/P) (First et al. 2001). The SCID Module A: Mood Episodes was used to classify patients according to the presence or absence of Lifetime episode of major depression. The SCID-I/P is a procedure designed to determine diagnoses and symptoms according to DSM-IV (American Psychiatric Association 1994).
Genotype 
[Units: Participants]
     
CC   23   31   54 
AC   29   32   61 
AA   15   8   23 


  Outcome Measures
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1.  Primary:   Mean Heavy Drinking Days Per Week by Medication Group   [ Time Frame: 12 weeks (from initiation to end of treatment) ]

2.  Secondary:   Mean Abstinent Days Per Week by Medication Group   [ Time Frame: 12 weeks ]

3.  Secondary:   Mean Heavy Drinking Days Per Week by Medication Group and rs2832407 Genotype   [ Time Frame: 12 weeks ]

4.  Secondary:   Mean Abstinent Days Per Week by Medication Group and rs2832407 Genotype   [ Time Frame: 12 weeks ]

5.  Secondary:   Severity of Alcohol-related Problems at End of Treatment   [ Time Frame: 12 weeks (from intiation to end of treatment) ]

6.  Secondary:   Gamma-glutamyl Transferase (GGT) at Midpoint   [ Time Frame: 6 weeks (from initiation to midpoint) ]

7.  Secondary:   Gamma-glutamyl Transferase (GGT) at End of Treatment   [ Time Frame: 12 weeks (from initiation to end of treatment) ]

8.  Secondary:   Mean Daily Alcohol Consumption   [ Time Frame: 12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Henry R. Kranzler, M.D.
Organization: University of Pennsylvania Perelman School of Medicine
phone: 215-386-6662
e-mail: kranzler@mail.med.upenn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Henry Kranzler, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00626925     History of Changes
Other Study ID Numbers: 08-052-2
P60AA003510 ( US NIH Grant/Contract Award Number )
M01RR006192 ( US NIH Grant/Contract Award Number )
Study First Received: February 21, 2008
Results First Received: April 8, 2016
Last Updated: August 2, 2016
Health Authority: United States: Institutional Review Board