Smoking CessationPhase 3NCT01399866
Cognitive Remediation With D-Cycloserine
A Phase 3 study testing D-cycloserine in people with Smoking Cessation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
One hundred seventy-five eligible participants will be enrolled with aim of randomizing 60 to a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment to prevent relapse to smoking. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- D-cycloserine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must have smoked an average of ≥ 10 cigarettes/day during the past 6 months
- have expired air CO ≥ 10 ppm or urine cotinine ≥ 100 ng/mL
- meet DSM-IV criteria for nicotine dependence
- aged 18 - 65
- Recently abstinent participants referred by a PCP, smoking cessation clinic or self referred must have an expired air CO < 10 ppm to confirm abstinence
Who cannot join
- Severe or uncontrolled medical or psychiatric illness
- History of multiple hospitalizations within the last six months for an ongoing medical condition
- Any significant, current and unstable cardiovascular disease, end stage renal failure, severe COPD requiring oxygen, any current unstable neurological disease, a history of seizures or epilepsy, or a history of head trauma with lasting neurological sequelae, will be excluded for their safety.
- Major depressive episode, mania or mixed episode in the prior 6 months
- Lifetime history of psychosis, delusional disorder, organic mental disorder by DSM-IV criteria, or ongoing cognitive impairment will also be excluded for their safety,
- Current excessive use of alcohol (>21 drinks/week in female subjects; >28 drinks/week in male subjects)
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- Current use of illicit drugs.
- Current steroid use, current, daily use of benzodiazepines, or participants who are unwilling to modify their benzodiazepine use will.
- Pregnant or breastfeeding women will be excluded, as well as women of childbearing potential who will not use a medically acceptable method of contraception (i.e. IUD, oral contraceptives).
- Participants who are deaf, blind, or experience any other significant sensory impairment that would preclude them from completing study procedures will also be excluded, as well as participants who are unable to understand study procedures or provide informed consent.
- Participants receiving isoniazid or ethionamide, or who have a known sensitivity to D-cycloserine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital - Center For Addiction Medicine
Boston, Massachusetts, 02114
About this study
Official title: Cognitive Remediation With D-cycloserine to Improve Smoking Cessation Outcomes
One hundred seventy-five eligible participants will be enrolled with aim of randomizing 60 to a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment to prevent relapse to smoking. Subjects who sign an informed consent, meet inclusion criteria, and demonstrate response to cue reactivity at the screening visit, will either be:
- started on approximately 3 weeks of either nicotine replacement therapy (NRT) at a dose of either 14 or 21 mg/day or varenicline titrated to 1.0 mg bid; decision of which method to use to quit smoking will be based on participant choice as well as taking into account any medical contraindications to either therapy.
- evaluated to confirm abstinence from smoking. Recently abstinent participants referred by a smoking cessation clinic, PCP or self referred must have an expired air CO < 10 ppm to confirm abstinence.
Subjects who are able to demonstrate 18-24 hours of abstinence prior to the first Cue Exposure Therapy Visit (CET I) will be eligible to be randomized to two visits of study medication and cue exposure treatment, spaced five to nine days apart. Subjects will complete 2 follow-up visits at 2-4 days and four weeks after the last CET visit. The entire study involves twelve visits and will last approximately ten weeks. For recently abstinent participants referred by a smoking cessation clinic, PCP or self referred, the study involves 7 visits (screening and baseline visit will be merged into one and there is no CBT component) and will last approximately 7 weeks.
- Conditions
- Smoking Cessation
- Being tested
- D-cycloserine, Placebo
- Keywords
- D-cycloserine, Smoking cues, Cognitive remediation, physiologic reactivity, craving
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
2 single weekly doses, 50 mg capsule
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 50 mg capsule,single dose, twice, one week apart, by mouth Receives: Drug: Placebo |
| D-cycloserine | Active comparator | 50 mg capsule,single dose, twice, one week apart, by mouth Receives: Drug: D-cycloserine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking.
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
Measured: Up to 6 weeks
Secondary outcomes (5)
Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance
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.
Measured: 6 weeks
Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate
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.
Measured: 6 weeks
Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram
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.
Measured: 6 weeks
Effect of D-cycloserine + Cue-exposure Treatment on Craving
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.
Measured: 6 weeks
Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cuesmeasured With the Emotional Stroop Task
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
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Eden Evins, Massachusetts General Hospital
- Investigators
- A. Eden Evins, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399866
- Sponsor's protocol ID
- 2011P000411
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2011
- Last updated
- 26 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation With D-cycloserine to Improve Smoking Cessation Outcomes
- ClinicalTrials.gov ID
- NCT01399866
- Acronym / sponsor ID
- 2011P000411
- Conditions
- Smoking Cessation
- Keywords
- D-cycloserine, Smoking cues, Cognitive remediation, physiologic reactivity, craving
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Posted 4 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One hundred seventy-five eligible participants will be enrolled with aim of randomizing 60 to a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment to prevent relapse to smoking. Subjects who sign an informed consent, meet inclusion criteria, and demonstrate response to cue reactivity at the screening visit, will either be:
- started on approximately 3 weeks of either nicotine replacement therapy (NRT) at a dose of either 14 or 21 mg/day or varenicline titrated to 1.0 mg bid; decision of which method to use to quit smoking will be based on participant choice as well as taking into account any medical contraindications to either therapy.
- evaluated to confirm abstinence from smoking. Recently abstinent participants referred by a smoking cessation clinic, PCP or self referred must have an expired air CO < 10 ppm to confirm abstinence.
Subjects who are able to demonstrate 18-24 hours of abstinence prior to the first Cue Exposure Therapy Visit (CET I) will be eligible to be randomized to two visits of study medication and cue exposure treatment, spaced five to nine days apart. Subjects will complete 2 follow-up visits at 2-4 days and four weeks after the last CET visit. The entire study involves twelve visits and will last approximately ten weeks. For recently abstinent participants referred by a smoking cessation clinic, PCP or self referred, the study involves 7 visits (screening and baseline visit will be merged into one and there is no CBT component) and will last approximately 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo50 mg capsule,single dose, twice, one week apart, by mouth |
| D-cycloserine | Active comparator | Drug: D-cycloserine50 mg capsule,single dose, twice, one week apart, by mouth |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have smoked an average of ≥ 10 cigarettes/day during the past 6 months
- have expired air CO ≥ 10 ppm or urine cotinine ≥ 100 ng/mL
- meet DSM-IV criteria for nicotine dependence
- aged 18 - 65
- Recently abstinent participants referred by a PCP, smoking cessation clinic or self referred must have an expired air CO < 10 ppm to confirm abstinence
Key exclusion criteria (11 listed)
- Severe or uncontrolled medical or psychiatric illness
- History of multiple hospitalizations within the last six months for an ongoing medical condition
- Any significant, current and unstable cardiovascular disease, end stage renal failure, severe COPD requiring oxygen, any current unstable neurological disease, a history of seizures or epilepsy, or a history of head trauma with lasting neurological sequelae, will be excluded for their safety.
- Major depressive episode, mania or mixed episode in the prior 6 months
- Lifetime history of psychosis, delusional disorder, organic mental disorder by DSM-IV criteria, or ongoing cognitive impairment will also be excluded for their safety,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-cycloserine2 single weekly doses, 50 mg capsule | Drug | D-cycloserine |
| Placebo | Drug | Placebo |
Primary outcome
Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking.
Time frame: 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
5 secondary outcomes
Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance
Time frame: 6 weeks
Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate
Time frame: 6 weeks
Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram
Time frame: 6 weeks
Effect of D-cycloserine + Cue-exposure Treatment on Craving
Time frame: 6 weeks
Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cuesmeasured With the Emotional Stroop Task
Time frame: Baseline and week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Eden Evins, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D-cycloserine in people with Smoking Cessation, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking. (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.