Cognitive Remediation With D-Cycloserine
NCT01399866, Phase 3, Completed, Massachusetts General Hospital; results first posted 2015-05-04
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Remediation With D-Cycloserine | ClinicalTrials.gov |
| NCT number | NCT01399866 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 150 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Massachusetts General Hospital | ClinicalTrials.gov |
| Conditions | Smoking Cessation | ClinicalTrials.gov |
| Interventions | D-cycloserine, Placebo | ClinicalTrials.gov |
| First posted | 2011-07-22 | ClinicalTrials.gov |
| Last updated | 2018-09-26 | ClinicalTrials.gov |
| Results first posted | 2015-05-04 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking. | Up to 6 weeks | 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 | ClinicalTrials.gov |
| Secondary | Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance | 6 weeks | 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. | ClinicalTrials.gov |
| Secondary | Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate | 6 weeks | 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. | ClinicalTrials.gov |
| Secondary | Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram | 6 weeks | 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. | ClinicalTrials.gov |
| Secondary | Effect of D-cycloserine + Cue-exposure Treatment on Craving | 6 weeks | 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. | ClinicalTrials.gov |
| Secondary | Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cuesmeasured With the Emotional Stroop Task | Baseline and week 6 | 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 | ClinicalTrials.gov |
Outcomes 6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking. | Up to 6 weeks | percentage of participants | NUMBER | ClinicalTrials.gov | |
| SECONDARY | Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance | 6 weeks | change in microSiemens | MEAN | ClinicalTrials.gov | |
| SECONDARY | Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate | 6 weeks | change in beats per minute | MEAN | ClinicalTrials.gov | |
| SECONDARY | Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram | 6 weeks | change in micro volts | MEAN | ClinicalTrials.gov | |
| SECONDARY | Effect of D-cycloserine + Cue-exposure Treatment on Craving | 6 weeks | change in units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cuesmeasured With the Emotional Stroop Task | Baseline and week 6 | Stroop interference Score | MEAN | ClinicalTrials.gov |
Results by group 12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking. | Placebo | 9 | percentage of participants | ClinicalTrials.gov | ||
| Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking. | D-cycloserine | 30 | percentage of participants | ClinicalTrials.gov | ||
| Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance | Placebo | 0.14 | Standard Deviation 0.46 | change in microSiemens | ClinicalTrials.gov | |
| Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance | D-cycloserine | 0.18 | Standard Deviation 0.31 | change in microSiemens | ClinicalTrials.gov | |
| Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate | Placebo | -0.13 | Standard Deviation 2.64 | change in beats per minute | ClinicalTrials.gov | |
| Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate | D-cycloserine | 0.98 | Standard Deviation 2.34 | change in beats per minute | ClinicalTrials.gov | |
| Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram | Placebo | 0.25 | Standard Deviation 1.02 | change in micro volts | ClinicalTrials.gov | |
| Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram | D-cycloserine | 0.46 | Standard Deviation 1.52 | change in micro volts | ClinicalTrials.gov | |
| Effect of D-cycloserine + Cue-exposure Treatment on Craving | Placebo | 2.28 | Standard Deviation 2.30 | change in units on a scale | ClinicalTrials.gov | |
| Effect of D-cycloserine + Cue-exposure Treatment on Craving | D-cycloserine | 1.44 | Standard Deviation 1.87 | change in units on a scale | ClinicalTrials.gov | |
| Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cuesmeasured With the Emotional Stroop Task | Placebo | 35.27 | Standard Deviation 74.93 | Stroop interference Score | ClinicalTrials.gov | |
| Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cuesmeasured With the Emotional Stroop Task | D-cycloserine | 50.30 | Standard Deviation 74.85 | Stroop interference Score | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 32 | ClinicalTrials.gov | |
| Overall Study | STARTED | D-cycloserine | 30 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo | 28 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | D-cycloserine | 28 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo | 4 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | D-cycloserine | 2 | ClinicalTrials.gov |
Adverse events 48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Anorexia | General disorders | Placebo | 2 | 32 | ClinicalTrials.gov | |
| other | Anorexia | General disorders | D-cycloserine | 4 | 30 | ClinicalTrials.gov | |
| other | Blurred vision | General disorders | Placebo | 3 | 32 | ClinicalTrials.gov | |
| other | Blurred vision | General disorders | D-cycloserine | 3 | 30 | ClinicalTrials.gov | |
| other | Constipation | Gastrointestinal disorders | Placebo | 6 | 32 | ClinicalTrials.gov | |
| other | Constipation | Gastrointestinal disorders | D-cycloserine | 6 | 30 | ClinicalTrials.gov | |
| other | Depressen mood | Psychiatric disorders | Placebo | 9 | 32 | ClinicalTrials.gov | |
| other | Depressen mood | Psychiatric disorders | D-cycloserine | 9 | 30 | ClinicalTrials.gov | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 9 | 32 | ClinicalTrials.gov | |
| other | Diarrhea | Gastrointestinal disorders | D-cycloserine | 2 | 30 | ClinicalTrials.gov | |
| other | Dizziness | General disorders | Placebo | 3 | 32 | ClinicalTrials.gov | |
| other | Dizziness | General disorders | D-cycloserine | 4 | 30 | ClinicalTrials.gov | |
| other | Dry mouth | General disorders | Placebo | 9 | 32 | ClinicalTrials.gov | |
| other | Dry mouth | General disorders | D-cycloserine | 7 | 30 | ClinicalTrials.gov | |
| other | Enuresis | General disorders | Placebo | 3 | 32 | ClinicalTrials.gov | |
| other | Enuresis | General disorders | D-cycloserine | 2 | 30 | ClinicalTrials.gov | |
| other | Fever | General disorders | Placebo | 2 | 32 | ClinicalTrials.gov | |
| other | Fever | General disorders | D-cycloserine | 1 | 30 | ClinicalTrials.gov | |
| other | Headache | General disorders | Placebo | 4 | 32 | ClinicalTrials.gov | |
| other | Headache | General disorders | D-cycloserine | 3 | 30 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Placebo | ClinicalTrials.gov | ||
| Total, all-cause mortality | D-cycloserine | ClinicalTrials.gov | ||
| Total, other adverse events | Placebo | 24 | 32 | ClinicalTrials.gov |
| Total, other adverse events | D-cycloserine | 24 | 30 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 1 | 32 | ClinicalTrials.gov |
| Total, serious adverse events | D-cycloserine | 0 | 30 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| D-cycloserine vs Placebo: serious adverse events | Trial comparisons |
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Emotional Stroop Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)