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Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Mclean Hospital
GlaxoSmithKline
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01188967
First received: August 5, 2010
Last updated: January 9, 2017
Last verified: January 2017
Results First Received: April 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Nicotine Dependence
Interventions: Drug: GSK598809
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
84 participants signed consent and 40 of those participants were found ineligible. 11 participants voluntarily withdrew consent. 4 participants were terminated by the investigator for reasons other than toxicity/adverse events (ie noncompliance). 11 participants were lost to follow up.

Reporting Groups
  Description
GSK598809 Treatment Group There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received 60 mg GSK598809 pills, the active treatment, for 6 weeks.
Placebo Group There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.

Participant Flow:   Overall Study
    GSK598809 Treatment Group   Placebo Group
STARTED   10   8 
COMPLETED   5   4 
NOT COMPLETED   5   4 
Withdrawal by Subject                1                1 
Physician Decision                1                1 
Lost to Follow-up                3                2 



  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.
No text entered.

Reporting Groups
  Description
Placebo Treatment Group There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received placebo pills.
GSK598809 Treatment Group There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received the active treatment: GSK598809 pills,60 mg/day.
Total Total of all reporting groups

Baseline Measures
   Placebo Treatment Group   GSK598809 Treatment Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   10   18 
Age [1] 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      8 100.0%      10 100.0%      18 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[1] The study only included participants aged 18-65.
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 48.7  (5)   46.7  (5)   47.7  (5) 
[1] The study only included participants aged 18-65
Gender 
[Units: Participants]
Count of Participants
     
Female      3  37.5%      4  40.0%      7  38.9% 
Male      5  62.5%      6  60.0%      11  61.1% 
Region of Enrollment 
[Units: Participants]
     
United States   8   10   18 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   4-week, Continuous Tobacco Abstinence at the End of the 6-week, Double Blind, Treatment Phase   [ Time Frame: Week 8 of the study ]

2.  Secondary:   7-day, Point-prevalence Tobacco Abstinence at the End of the First Week of Exposure to GSK598809/Placebo   [ Time Frame: Week 3 of the study ]

3.  Secondary:   7-day, Point-prevalence Tobacco Abstinence at the End of 6 Weeks Exposure to GSK598809/Placebo   [ Time Frame: Week 8 of the study ]

4.  Secondary:   Number of Participants With 7-day, Point-prevalence Tobacco Abstinence 2-weeks After Discontinuation of Double Blind Study Medications   [ Time Frame: Week 10 of the study ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Maurizio Fava M.D.
Organization: Massachusetts General Hospital
phone: 617-724-2513
e-mail: mfava@partners.org



Responsible Party: Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01188967     History of Changes
Other Study ID Numbers: NIDA-19378-5
U01DA019378 ( U.S. NIH Grant/Contract )
Study First Received: August 5, 2010
Results First Received: April 7, 2015
Last Updated: January 9, 2017