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Effectiveness of GW468816, an NMDA Glycine Site Antagonist, for Prevention of Relapse to Smoking

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ClinicalTrials.gov Identifier: NCT00218465
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 20, 2010
Last Update Posted : March 24, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Mclean Hospital
GlaxoSmithKline
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Nicotine Dependence
Interventions Drug: GW468816
Drug: Placebo Comparator: Placebo
Enrollment 264

Recruitment Details  
Pre-assignment Details  
Arm/Group Title 816 Group Placebo
Hide Arm/Group Description Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial. Placebo group for 5 week relapse prevention trial.
Period Title: Overall Study
Started 50 48
Completed 33 30
Not Completed 17 18
Arm/Group Title 816 Group Placebo Total
Hide Arm/Group Description Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial. Placebo group for 5 week relapse prevention trial. Total of all reporting groups
Overall Number of Baseline Participants 50 48 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
48
 100.0%
98
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 48 participants 98 participants
49.3  (10.5) 46.5  (10.4) 47.9  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 participants
Female
50
 100.0%
48
 100.0%
98
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 48 participants 98 participants
50 48 98
1.Primary Outcome
Title Time to Relapse to Smoking in the 5-week Relapse Prevention Phase.
Hide Description [Not Specified]
Time Frame 5 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 816 Group Placebo
Hide Arm/Group Description:
Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
Placebo group for 5 week relapse prevention trial.
Overall Number of Participants Analyzed 50 48
Mean (Standard Deviation)
Unit of Measure: days
14.5  (14.0) 12.4  (12.5)
2.Primary Outcome
Title Number of Abstinent and Nonabstinent Participants at End of 5 Week Placebo-controlled Relapse Prevention Trial
Hide Description [Not Specified]
Time Frame 5 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 816 Group Placebo
Hide Arm/Group Description:
Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
Placebo group for 5 week relapse prevention trial.
Overall Number of Participants Analyzed 50 48
Measure Type: Number
Unit of Measure: participants
50 48
3.Primary Outcome
Title Days to Relapse Within the 60 Days Following Randomization
Hide Description [Not Specified]
Time Frame 60 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 816 Group Placebo
Hide Arm/Group Description:
Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
Placebo group for 5 week relapse prevention trial.
Overall Number of Participants Analyzed 50 48
Mean (Standard Deviation)
Unit of Measure: days
20.8  (18.3) 20.6  (20.3)
Time Frame Five weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 816 Group Placebo
Hide Arm/Group Description Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial. Placebo group for 5 week relapse prevention trial.
All-Cause Mortality
816 Group Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
816 Group Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/50 (4.00%)      1/48 (2.08%)    
Gastrointestinal disorders     
Diverticulitis   0/50 (0.00%)  0 1/48 (2.08%)  1
Respiratory, thoracic and mediastinal disorders     
small cell adenocarcinoma   1/50 (2.00%)  1 0/48 (0.00%)  0
Skin and subcutaneous tissue disorders     
facial edema   1/50 (2.00%)  1 0/48 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
816 Group Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/50 (62.00%)      31/48 (64.58%)    
Cardiac disorders     
Cardiovascular   3/50 (6.00%)  3 2/48 (4.17%)  2
Gastrointestinal disorders     
Gastrointestinal   14/50 (28.00%)  14 11/48 (22.92%)  11
General disorders     
General/Administration Site   8/50 (16.00%)  8 7/48 (14.58%)  7
Musculoskeletal and connective tissue disorders     
Musculoskeletal   6/50 (12.00%)  6 6/48 (12.50%)  6
Nervous system disorders     
Nervous System   12/50 (24.00%)  12 15/48 (31.25%)  15
Respiratory, thoracic and mediastinal disorders     
Respiratory   6/50 (12.00%)  6 13/48 (27.08%)  13
Skin and subcutaneous tissue disorders     
Dermatological   4/50 (8.00%)  4 2/48 (4.17%)  2
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
Name/Title: Sara Carlini
Organization: Center for Addiction Medicine
Phone: 617-643-1990
Responsible Party: Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00218465     History of Changes
Other Study ID Numbers: NIDA-19378-2
U01DA019378 ( U.S. NIH Grant/Contract )
IND 74964 ( Other Identifier: IND Number )
First Submitted: September 16, 2005
First Posted: September 22, 2005
Results First Submitted: August 2, 2010
Results First Posted: December 20, 2010
Last Update Posted: March 24, 2017