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Trial record 78 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

D-cycloserine (DCS) Pretreatment + CBT + Nicotine Replacement Therapy for Smoking Cessation (DCS) (DCS)

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ClinicalTrials.gov Identifier: NCT01842334
Recruitment Status : Terminated (left institution protocol closed)
First Posted : April 29, 2013
Results First Posted : August 1, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Nicotine Dependence
Smoking Cessation
Interventions Behavioral: Cognitive Behavioral Therapy
Drug: Nicotine Replacement Therapy
Enrollment 22
Recruitment Details  
Pre-assignment Details 9 out of the 21 subject screened did not qualify for randomization. 6 of the subjects were no longer interested in participating after the screening visit, 2 did not return repeated phone calls by study staff and 1 subject did not qualify due to being on probation.
Arm/Group Title D-cycloserine Placebo
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250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.

Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.

Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.

one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy

Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.

Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.

Period Title: Overall Study
Started 5 7
Completed 2 3
Not Completed 3 4
Reason Not Completed
Withdrawal by Subject             3             3
Moved away mid-study             0             1
Arm/Group Title D-cycloserine Placebo Total
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250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.

Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.

Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.

one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy

Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.

Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.

Total of all reporting groups
Overall Number of Baseline Participants 5 7 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 7 participants 12 participants
30  (6.96) 39.57  (15.79) 35.58  (13.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 12 participants
Female
2
  40.0%
3
  42.9%
5
  41.7%
Male
3
  60.0%
4
  57.1%
7
  58.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  20.0%
1
  14.3%
2
  16.7%
White
4
  80.0%
6
  85.7%
10
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Cigs/Day  
Mean (Standard Deviation)
Unit of measure:  Cigarettes/day
Number Analyzed 5 participants 7 participants 12 participants
13.34  (2.18) 12.87  (2.01) 13.04  (1.97)
1.Primary Outcome
Title Change From Baseline in Cigarette Smoking in Treatment Seeking Nicotine Dependent Outpatients
Hide Description Cigarette smoking at 10 weeks as measured by carbon monoxide levels and self-report measurements.
Time Frame During Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Only the 5 completers of this study who made it to week 10 could have this measure analyzed.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:

250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.

Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.

Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.

one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy

Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.

Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.

Overall Number of Participants Analyzed 2 3
Mean (Standard Deviation)
Unit of Measure: Cigarettes/day
2.57  (3.63) 0.29  (0.25)
Time Frame Adverse even data was collected from the baseline visit until the end of the study (14 weeks after baseline)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description

250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.

Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.

Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.

one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy

Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.

Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.

All-Cause Mortality
D-cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/7 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
D-cycloserine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/7 (0.00%)    
General disorders     
Nausea due to Nicotine Patch  [1]  1/5 (20.00%)  1 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Only 1 subject in the study reported nausea associated with the nicotine patch. The nicotine patch dosage was decreased from 21mg to 14mg by the PI following the procedure outlined in the protocol.
Due to lack of sufficient funds/resources, the sample size for this study is not large enough to extract any conclusive results. The high number of subjects withdrawing from the study early also hinders any possible conclusions.
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: Dr. Kevin P Hill, Director of the Division of Addiction Psychiatry
Organization: Beth Israel Deaconess Medical Center
Phone: 617-667-1504
Responsible Party: Kevin P. Hill, MD, MHS, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01842334     History of Changes
Other Study ID Numbers: 2012P001707
First Submitted: April 25, 2013
First Posted: April 29, 2013
Results First Submitted: July 9, 2018
Results First Posted: August 1, 2018
Last Update Posted: August 31, 2018