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Trial record 77 of 592 for:    binge eating disorder

An Open Label Trial of Bupropion and Naltrexone for Binge Drinking

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ClinicalTrials.gov Identifier: NCT02842073
Recruitment Status : Completed
First Posted : July 22, 2016
Results First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Collaborator:
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Binge Drinking
Interventions Drug: Naltrexone
Drug: Bupropion
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naltrexone and Buproprion
Hide Arm/Group Description Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Period Title: Overall Study
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Naltrexone and Buproprion
Hide Arm/Group Description Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
33.1  (2.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
10
  83.3%
Male
2
  16.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  25.0%
White
9
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
 100.0%
Number of Binge Drinking Days in 90 days prior to screening  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 12 participants
17.3  (7.8)
Intensity of Binge Drinking prior to Study   [1] 
Mean (Standard Deviation)
Unit of measure:  Drinks/binge drinking day
Number Analyzed 12 participants
8.4  (1.0)
[1]
Measure Description: The mean number of drinks/binge drinking day in the 90 days prior to screening.
Craving for Alcohol   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants
11.25  (7.1)
[1]
Measure Description: The PACS is a five-item self-administered instrument for assessing craving. Frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking. The final item asks the responder to provide an average rating of his/her craving over the course of the past week. The questions on the PACS use descriptors coupled with numerical ratings ranging from 0 to 6 with the highest possible total score of 30. Higher scores reflect a higher level of craving.
1.Primary Outcome
Title Number of Participants With Treatment-Associated Adverse Events
Hide Description Tolerability assessed by specifically probing for intervention-associated adverse effects.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone and Buproprion
Hide Arm/Group Description:
Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Headache
5
  41.7%
Insomnia
2
  16.7%
Dizziness
2
  16.7%
2.Primary Outcome
Title Number of Participants Discontinuing Subsequent to Defined Intolerance
Hide Description Retention was evaluated indirectly by accounting for those participants who discontinued either naltrexone or bupropion or study participation itself due to intolerance.
Time Frame Throughout study, a total of approximately 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone and Buproprion
Hide Arm/Group Description:
Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Discontinued: Naltrexone
3
  25.0%
Discontinued: Buproprion
1
   8.3%
Discontinued: Study
1
   8.3%
3.Primary Outcome
Title Number of Binge Drinking Days During Treatment
Hide Description The number of binge drinking days during treatment with bupropion + naltrexone
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone and Buproprion
Hide Arm/Group Description:
Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: days
3.2  (2.9)
4.Secondary Outcome
Title Final Penn Alcohol Craving Scale (PACS) Score
Hide Description Craving for alcohol will be assessed using the Penn Alcohol Craving Scale (PACS) The PACS is a five-item self-administered instrument for assessing craving. Frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking. The final item asks the responder to provide an average rating of his/her craving over the course of the past week. The questions on the PACS use descriptors coupled with numerical ratings ranging from 0 to 6 with the highest possible total score of 30. Higher scores reflect a higher level of craving. This outcome measure is the final PACS total score obtained in the trial.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone and Buproprion
Hide Arm/Group Description:
Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.4  (4.2)
5.Secondary Outcome
Title Mean Number of Drinks/Binge Drinking Day During Treatment
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone and Buproprion
Hide Arm/Group Description:
Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: drinks/binge drinking day
3.3  (0.9)
Time Frame Throughout the 12-week study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone and Buproprion
Hide Arm/Group Description Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
All-Cause Mortality
Naltrexone and Buproprion
Affected / at Risk (%)
Total   0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Naltrexone and Buproprion
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naltrexone and Buproprion
Affected / at Risk (%) # Events
Total   11/12 (91.67%)    
Gastrointestinal disorders   
Constipation *  3/12 (25.00%)  3
Nausea *  2/12 (16.67%)  2
General disorders   
Low energy *  2/12 (16.67%)  2
Reduced Appetite *  1/12 (8.33%)  1
Dry Mouth *  1/12 (8.33%)  1
Nervous system disorders   
Headache *  5/12 (41.67%)  5
Insomnia *  2/12 (16.67%)  2
Dizziness *  2/12 (16.67%)  2
Irritability *  3/12 (25.00%)  3
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: James C Garbutt, MD
Organization: University of North Carolina at Chapel Hill
Phone: 984-974-2201
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02842073     History of Changes
Other Study ID Numbers: 16-1370
TTSA018P1 ( Other Identifier: NCTraCS )
First Submitted: June 15, 2016
First Posted: July 22, 2016
Results First Submitted: October 31, 2018
Results First Posted: December 25, 2018
Last Update Posted: December 25, 2018