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Cognitive Remediation With D-Cycloserine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01399866
First Posted: July 22, 2011
Last Update Posted: April 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital
Results First Submitted: April 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Smoking Cessation
Interventions: Drug: D-cycloserine
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
One hundred fifty participants were enrolled (signed consent), but only 98 were found eligible and started study procedures. Eighty one participants started smoking cessation CBT, and 62 finished and were randomized to receive either D-cycloserine or identical placebo added to exposure treatment to prevent relapse to smoking.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants received their choice of nicotine patch or varenicline (0.5 mg per day for 3 days, 0.5 mg bid for 4 days, 1 mg bid for 4 wks) and weekly cognitive behavioral therapy for smoking cessation.

Reporting Groups
  Description
Placebo

50 mg capsule,single dose, twice, one week apart, by mouth

Placebo

D-cycloserine

50 mg capsule,single dose, twice, one week apart, by mouth

D-cycloserine: 2 single weekly doses, 50 mg capsule


Participant Flow:   Overall Study
    Placebo   D-cycloserine
STARTED   32   30 
COMPLETED   28   28 
NOT COMPLETED   4   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.
After 4 wks of smoking cessation treatment and CBT, participants who had 18 hrs of abstinence, smoking no cigarettes for at least 18 hrs and CO<10ppm were randomized

Reporting Groups
  Description
Placebo

50 mg capsule,single dose, twice, one week apart, by mouth

Placebo

D-cycloserine

50 mg capsule,single dose, twice, one week apart, by mouth

D-cycloserine: 2 single weekly doses, 50 mg capsule

Total Total of all reporting groups

Baseline Measures
   Placebo   D-cycloserine   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   30   62 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.1  (11.4)   48.4  (12.4)   47.7  (11.8) 
Gender 
[Units: Participants]
     
Female   19   22   41 
Male   13   8   21 


  Outcome Measures

1.  Primary:   Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking.   [ Time Frame: Up to 6 weeks ]

2.  Secondary:   Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance   [ Time Frame: Up to 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate   [ Time Frame: Up to 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram   [ Time Frame: Up to 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Effect of D-cycloserine + Cue-exposure Treatment on Craving   [ Time Frame: Up to 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cues   [ Time Frame: Up to 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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: A. Eden Evins, MD, MPH. Director of the MGH-Harvard Center for Addiction Medicine
Organization: Massachusetts General Hospital - Harvard Medical School
phone: 6176434679
e-mail: a_eden_evins@hms.harvard.edu



Responsible Party: A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01399866     History of Changes
Other Study ID Numbers: 2011P000411
First Submitted: July 19, 2011
First Posted: July 22, 2011
Results First Submitted: April 15, 2015
Results First Posted: May 4, 2015
Last Update Posted: April 13, 2016