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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
816 Group Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
Placebo Placebo group for 5 week relapse prevention trial.

Participant Flow:   Overall Study
    816 Group   Placebo
STARTED   50   48 
COMPLETED   33   30 
NOT COMPLETED   17   18 



  Baseline Characteristics

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.
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Reporting Groups
  Description
816 Group Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
Placebo Placebo group for 5 week relapse prevention trial.
Total Total of all reporting groups

Baseline Measures
   816 Group   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   48   98 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 49.3  (10.5)   46.5  (10.4)   47.9  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      50 100.0%      48 100.0%      98 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   50   48   98 


  Outcome Measures

1.  Primary:   Time to Relapse to Smoking in the 5-week Relapse Prevention Phase.   [ Time Frame: 5 weeks ]

2.  Primary:   Number of Abstinent and Nonabstinent Participants at End of 5 Week Placebo-controlled Relapse Prevention Trial   [ Time Frame: 5 weeks ]

3.  Primary:   Days to Relapse Within the 60 Days Following Randomization   [ Time Frame: 60 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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  More Information

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
e-mail: scarlini@partners.org



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