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Trial record 47 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Cognitive Remediation With D-Cycloserine

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.
ClinicalTrials.gov Identifier: NCT01399866
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : May 4, 2015
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital

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
Enrollment 150
Recruitment Details 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 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.
Arm/Group Title Placebo D-cycloserine
Hide Arm/Group Description

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

Placebo

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

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

Period Title: Overall Study
Started 32 30
Completed 28 28
Not Completed 4 2
Arm/Group Title Placebo D-cycloserine Total
Hide Arm/Group Description

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

Placebo

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

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

Total of all reporting groups
Overall Number of Baseline Participants 32 30 62
Hide Baseline Analysis Population Description
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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 30 participants 62 participants
47.1  (11.4) 48.4  (12.4) 47.7  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 30 participants 62 participants
Female
19
  59.4%
22
  73.3%
41
  66.1%
Male
13
  40.6%
8
  26.7%
21
  33.9%
1.Primary Outcome
Title Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking.
Hide Description Participants assigned to receive D-cycloserine + CET will achieve better maintenance of tobacco abstinence, as assessed with self-report and saliva cotinine measurements, than those who receive placebo + CET at week 6 follow up visits
Time Frame Up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo D-cycloserine
Hide Arm/Group Description:

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

Placebo

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

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

Overall Number of Participants Analyzed 32 30
Measure Type: Number
Unit of Measure: percentage of participants
9 30
2.Secondary Outcome
Title Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance
Hide Description

Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (skin conductance) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.

Subjects were presented with 2 blocks of audio recordings, one smoking-related script and one neutral script unrelated to smoking. Assessment of skin conductance was made after each audio recording was presented. The skin conductance mean was obtained for each script (smoking vs neutral). Differences in responsivity (skin conductance) to smoking cues (smoking script) was compared between subjects who received D-cycloserine + CET and subjects who received placebo + CET.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo D-cycloserine
Hide Arm/Group Description:

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

Placebo

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

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

Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: change in microSiemens
0.14  (0.46) 0.18  (0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, D-cycloserine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.574
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, D-cycloserine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.747
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate
Hide Description

Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (heart rate) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.

Subjects were presented with 2 blocks of audio recordings, one smoking-related script and one neutral script unrelated to smoking. Heart rate measurement was obtained after each audio recording was presented. The heart rate mean was obtained for each script (smoking vs neutral). Differences in responsivity (heart rate) to smoking cues (smoking script) was compared between subjects who received D-cycloserine + CET and subjects who received placebo + CET.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo D-cycloserine
Hide Arm/Group Description:

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

Placebo

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

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

Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: change in beats per minute
-0.13  (2.64) 0.98  (2.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, D-cycloserine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram
Hide Description

Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (electromyogram) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.

Subjects were presented with 2 blocks of audio recordings, one smoking-related script and one neutral script unrelated to smoking. Electromyogram of the corrugator (EMGc)measurement was obtained after each audio recording was presented. The EMGc mean was obtained for each script (smoking vs neutral). Differences in responsivity (EMGc) to smoking cues (smoking script) was compared between subjects who received D-cycloserine + CET and subjects who received placebo + CET.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo D-cycloserine
Hide Arm/Group Description:

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

Placebo

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

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

Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: change in micro volts
0.25  (1.02) 0.46  (1.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, D-cycloserine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.818
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Effect of D-cycloserine + Cue-exposure Treatment on Craving
Hide Description Recently abstinent smokers assigned to receive D-cycloserine + CET will have less craving at the Post-Extinction Assessment than those who receive placebo + CET The scale used to measure craving was a Visual Analogue Scale 0 (no desire at all) - 7 (unable to resist) Subjects were presented with 2 blocks of audio recordings, one smoking-related script and one neutral script unrelated to smoking. Craving level was obtained after each audio recording was presented. The craving mean was obtained for each script (smoking vs neutral). Differences in craving level response to smoking cues (smoking script) was compared between subjects who received D-cycloserine + CET and subjects who received placebo + CET.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo D-cycloserine
Hide Arm/Group Description:

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

Placebo

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

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

Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: change in units on a scale
2.28  (2.30) 1.44  (1.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, D-cycloserine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.123
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cuesmeasured With the Emotional Stroop Task
Hide Description Recently abstinent smokers assigned to receive D-cycloserine + CET will have less attentional bias (Smoking Stroop task) toward smoking cues at the Post-Extinction Assessment than those who receive placebo + CET The Emotional Stroop uses smoking-related words and neutral words to measure attentional bias toward smoking related cues. Attentional bias is a central feature of many cognitive theories of addiction and can be measured with an emotional analog of the Stroop task. In this task, participants name the colors in which words are printed, and the words vary in their relevance to smoking. Extensive research has shown that patients are often slower to name the color of a word associated with concerns relevant to their clinical condition due to distraction by the meaning of the word(Williams, Mathews et al. 1996). The Stroop interference Score is obtained by subtracting Reaction Time (RT) to smoking minus the Reaction Time to neutral
Time Frame Baseline and week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo D-cycloserine
Hide Arm/Group Description:

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

Placebo

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

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

Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: Stroop interference Score
35.27  (74.93) 50.30  (74.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, D-cycloserine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo D-cycloserine
Hide Arm/Group Description

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

Placebo

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

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

All-Cause Mortality
Placebo D-cycloserine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo D-cycloserine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/32 (3.13%)   0/30 (0.00%) 
Musculoskeletal and connective tissue disorders     
compression fracture  1/32 (3.13%)  0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo D-cycloserine
Affected / at Risk (%) Affected / at Risk (%)
Total   24/32 (75.00%)   24/30 (80.00%) 
Gastrointestinal disorders     
Constipation  6/32 (18.75%)  6/30 (20.00%) 
Diarrhea  9/32 (28.13%)  2/30 (6.67%) 
Nausea  5/32 (15.63%)  2/30 (6.67%) 
Vomiting  2/32 (6.25%)  2/30 (6.67%) 
General disorders     
Anorexia  2/32 (6.25%)  4/30 (13.33%) 
Blurred vision  3/32 (9.38%)  3/30 (10.00%) 
Dizziness  3/32 (9.38%)  4/30 (13.33%) 
Dry mouth  9/32 (28.13%)  7/30 (23.33%) 
Enuresis  3/32 (9.38%)  2/30 (6.67%) 
Fever  2/32 (6.25%)  1/30 (3.33%) 
Headache  4/32 (12.50%)  3/30 (10.00%) 
Hypersalivation  2/32 (6.25%)  2/30 (6.67%) 
Insomnia  8/32 (25.00%)  7/30 (23.33%) 
Malaise  7/32 (21.88%)  4/30 (13.33%) 
Drowsiness  6/32 (18.75%)  5/30 (16.67%) 
Stiffness  3/32 (9.38%)  4/30 (13.33%) 
Other  14/32 (43.75%)  15/30 (50.00%) 
Psychiatric disorders     
Depressen mood  9/32 (28.13%)  9/30 (30.00%) 
Irritability  11/32 (34.38%)  9/30 (30.00%) 
Restlessness  2/32 (6.25%)  7/30 (23.33%) 
Respiratory, thoracic and mediastinal disorders     
Sore throat  4/32 (12.50%)  6/30 (20.00%) 
Skin and subcutaneous tissue disorders     
Skin rash  5/32 (15.63%)  4/30 (13.33%) 
Urticaria  2/32 (6.25%)  5/30 (16.67%) 
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
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: September 26, 2018