SmokersPhase 2NCT00827281
D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation (DCSSmoking)
A Phase 2 study testing D-cycloserine in people with Smokers, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This study examines whether isolated doses of D-cycloserine enhance the efficacy of CBT for smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smokers
- What is being tested?
- D-cycloserine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to 15 Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Be a regular smoker for at least one year 3. Currently smoke an average of at least 10 cigarettes per day 4. Report a motivation to quit smoking in the next month of at least 5 on a 10 point scale 5. Score 20 or greater on the 16-item Anxiety Sensitivity Index (Schmidt \& Joiner, 2002).
Who cannot join
- Current diagnosis of a psychotic, eating, developmental or bipolar disorder (as determined by the SCID)
- Current anxiety or mood disorder rated moderate or greater (i.e., CGI score of 4 or greater for an anxiety or depressive disorder or any current or recent-1 year--suicidal ideation)
- Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
- Current use of isoniazid psychotropic medication
- A history of significant medical condition, such as cardiovascular, neurologic, gastrointestinal, pregnancy and/or breast feeding, history of seizure (other than febrile seizures in childhood) or other systemic illness and/or be deemed as currently unhealthy in the context of a complete physical examination
- Limited mental competency and the inability to give informed, voluntary, written consent to participate,
Show all 11Show fewer
- Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt,
- Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of anxiety or mood disorder other than general supportive therapy initiated at least 3 months prior to the study
- Use of other tobacco products
- Planning on moving (outside of the immediate area) in the next six months
- Insufficient command of the English language (i.e., they cannot carry on a conversation with an interviewer in the English language or read associated text).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation
This study examines whether isolated doses of D-cycloserine enhance the efficacy of CBT for smoking cessation.
Read the detailed description
In comparison to placebo-augmented cognitive behavioral therapy (CBT), D-cycloserine-augmented CBT will lead to a greater reduction in both short-and long-term point prevalence abstinence as well as time to first smoking lapse and time to smoking relapse.
- Conditions
- Smokers
- Being tested
- D-cycloserine, Placebo
- Keywords
- DCS, CBT, smoking, tobacco
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
Also called DCS
Single dosage prior to sessions 3, 4 \& 5
PlaceboDrug
Single dosage prior to sessions 3, 4 \& 5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DCS-augmented CBT for smoking cessation Receives: Drug: D-cycloserine |
| 2 | Placebo comparator | Placebo-augmented CBT for smoking cessation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon monoxide analysis
Measured: Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29
Cotinine levels in saliva
Measured: Baseline, Weeks 21 & 29
Secondary outcomes (4)
Anxiety Sensitivity Index
Measured: Baseline, Weeks 5, 6, 7, 8, 9, 13, 21 & 29
Minnesota Withdrawal Scale
Measured: Each visit
Mood & Anxiety Symptom Questionnaire
Measured: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, & 8
Smoking Cessation Self-Efficacy
Measured: Baseline, Weeks 3, 4, 5, 6, 7, 8, 9, 13, 21 & 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startAug 2008
- Primary completion15 Jul 2015
- Study completion15 Jul 2015
Why it stopped: Study was not funded and pilot work proved impractical.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokersStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Otto, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827281
- Sponsor's protocol ID
- 1728
- Status last verified
- Apr 2017
- First submitted
- 21 Jan 2009
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00827281
- Acronym / sponsor ID
- 1728
- Conditions
- Smokers
- Keywords
- DCS, CBT, smoking, tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not funded and pilot work proved impractical.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- Aug 2008 (actual)
- Primary completion
- 15 Jul 2015 (actual)
- Study completion
- 15 Jul 2015 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines whether isolated doses of D-cycloserine enhance the efficacy of CBT for smoking cessation.
Detailed description
In comparison to placebo-augmented cognitive behavioral therapy (CBT), D-cycloserine-augmented CBT will lead to a greater reduction in both short-and long-term point prevalence abstinence as well as time to first smoking lapse and time to smoking relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: D-cycloserineDCS-augmented CBT for smoking cessation |
| 2 | Placebo comparator | Drug: PlaceboPlacebo-augmented CBT for smoking cessation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Be a regular smoker for at least one year 3. Currently smoke an average of at least 10 cigarettes per day 4. Report a motivation to quit smoking in the next month of at least 5 on a 10 point scale 5. Score 20 or greater on the 16-item Anxiety Sensitivity Index (Schmidt \& Joiner, 2002).
Key exclusion criteria (11 listed)
- Current diagnosis of a psychotic, eating, developmental or bipolar disorder (as determined by the SCID)
- Current anxiety or mood disorder rated moderate or greater (i.e., CGI score of 4 or greater for an anxiety or depressive disorder or any current or recent-1 year--suicidal ideation)
- Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
- Current use of isoniazid psychotropic medication
- A history of significant medical condition, such as cardiovascular, neurologic, gastrointestinal, pregnancy and/or breast feeding, history of seizure (other than febrile seizures in childhood) or other systemic illness and/or be deemed as currently unhealthy in the context of a complete physical examination
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-cycloserineAlso: DCSSingle dosage prior to sessions 3, 4 \& 5 | Drug | 1 |
| PlaceboSingle dosage prior to sessions 3, 4 \& 5 | Drug | 2 |
Primary outcome
Carbon monoxide analysis
Time frame: Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29
Cotinine levels in saliva
Time frame: Baseline, Weeks 21 & 29
4 secondary outcomes
Anxiety Sensitivity Index
Time frame: Baseline, Weeks 5, 6, 7, 8, 9, 13, 21 & 29
Minnesota Withdrawal Scale
Time frame: Each visit
Mood & Anxiety Symptom Questionnaire
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, & 8
Smoking Cessation Self-Efficacy
Time frame: Baseline, Weeks 3, 4, 5, 6, 7, 8, 9, 13, 21 & 29
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-cycloserine in people with Smokers, run by Boston University Charles River Campus 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 1 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: withdrawn, as of the sponsor's last update on 1 May 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Carbon monoxide analysis (time frame: Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29). The study lists 2 primary outcomes in all. 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 1 May 2017.