Cognitive Remediation With D-Cycloserine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01399866
First received: July 19, 2011
Last updated: April 15, 2015
Last verified: April 2015
Results First Received: April 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
No text entered.

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
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.
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. After 4 wks of treatment, 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  
Number of Participants  
[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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   No


  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
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  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


No publications provided


Responsible Party: A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01399866     History of Changes
Other Study ID Numbers: 2011P000411
Study First Received: July 19, 2011
Results First Received: April 15, 2015
Last Updated: April 15, 2015
Health Authority: United States: Institutional Review Board