Nicotine DependencePhase 1/2DCSNCT01842334
D-cycloserine (DCS) Pretreatment + CBT + Nicotine Replacement Therapy for Smoking Cessation (DCS)
A Phase 1/2 study testing Cognitive Behavioral Therapy and Nicotine Replacement Therapy in people with Nicotine Dependence and Smoking Cessation, run by Mclean Hospital at 1 site in United States.
Trial summary
1. Compare the relative efficacy of ten weeks of once weekly 250 mg D-cycloserine (DCS) vs. placebo (both in conjunction with cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT) on reducing cigarette smoking in treatment-seeking nicotine-dependent outpatients. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Smoking Cessation
- What is being tested?
- Cognitive Behavioral Therapy and Nicotine Replacement Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Aug 2017
- Phase
- Phase 1/2
- 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
- 1) Age range 18-65 years; 2) DSM-IV diagnosis of nicotine dependence, based on the Structured Clinical Interview for DSM-IV (SCID) (First et al. 1996); 3) express a desire to quit cigarette smoking within the next 30 days; 4) smokes greater than or equal to 10 cigarettes per day and less than or equal to 20 cigarettes per day; 5) an expired carbon monoxide (CO) determination greater than or equal to 10 ppm over ambient values; 6) for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and multiple subsequent pregnancy tests; 7) consent for us to communicate with their prescribing clinician; 8) furnish the names of 2 locators, who would assist study staff in locating them during the study period; 9) live close enough to McLean Hospital to attend study visits; 10) plan to remain in the Boston area for the next 4 months; and 11) are willing and able to sign informed consent.
Who cannot join
- 1) Current diagnosis of other drug or alcohol dependence (other than nicotine); 2) significant cardiac disease; 3) current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder (taking psychiatric medications, aside from wellbutrin, is not an exclusionary criterion); 4) have a current medical condition (including significant laboratory abnormalities, such as liver function tests >5 times the upper limit of normal range) that could prevent regular study attendance; 5) have mental retardation or organic mental disorder; 6) exhibit acutely dangerous or suicidal behavior; 7) are pregnant, nursing, or, if a woman of childbearing potential, not using a form of birth control judged by the Principal Investigator to be effective; 8) current NRT or other smoking cessation treatment;9) current CBT for smoking cessation; 10) current smokeless tobacco use; 11) inability to read or write in English;12) has epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D-cycloserine (DCS) Pretreatment + Cognitive Behavioral Therapy and Nicotine Replacement Therapy for Smoking Cessation
- Compare the relative efficacy of ten weeks of once weekly 250 mg D-cycloserine (DCS) vs. placebo (both in conjunction with cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT) on reducing cigarette smoking in treatment-seeking nicotine-dependent outpatients.
- Compare the relative efficacy of ten weeks of once weekly 250 mg DCS vs. placebo on the process of extinction and the memory encoding process.
Read the detailed description
The investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to develop a medication to treat nicotine dependence. In a randomized, double-blind, placebo-controlled trial, 40 nicotine-dependent participants ages 18-65 will receive cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT) over a 10- week period, with half receiving D-cycloserine (DCS) pretreatment and half receiving placebo. Participants will receive either 250 mg DCS or placebo prior to weekly CBT sessions in addition to NRT over a 10-week treatment period. The investigators also aim to determine the effects of DCS on performance on neuropsychological tests. A 10-week treatment period will be followed by follow-up assessments including neuropsychological tests at 1 and 3 months post-treatment. Primary outcomes will include smoking as measured by carbon monoxide levels and self-report measurements.
- Conditions
- Nicotine Dependence, Smoking Cessation
- Being tested
- Cognitive Behavioral Therapy, Nicotine Replacement Therapy
- Keywords
- Nicotine Dependence, Smoking Cessation, D-cycloserine
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
CBT administered to to both DCS and placebo group.
Nicotine Replacement TherapyDrug
Also called NRT
NRT administered to both DCS and placebo group.
| Study group | Role | What they receive |
|---|---|---|
| D-cycloserine | Experimental | 250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy. Receives: Behavioral: Cognitive Behavioral Therapy; Drug: Nicotine Replacement Therapy |
| Placebo | Placebo comparator | one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy Receives: Behavioral: Cognitive Behavioral Therapy; Drug: Nicotine Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Cigarette Smoking in Treatment Seeking Nicotine Dependent Outpatients
Cigarette smoking at 10 weeks as measured by carbon monoxide levels and self-report measurements.
Measured: During Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: left institution protocol closed
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 Nicotine DependenceStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association
- Responsible party
- Principal investigator, Kevin P. Hill, MD, MHS, Mclean Hospital
- Investigators
- Kevin P. Hill, MD, MHS, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842334
- Sponsor's protocol ID
- 2012P001707
- Acronym
- DCS
- Status last verified
- Aug 2018
- First submitted
- 25 Apr 2013
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-cycloserine (DCS) Pretreatment + Cognitive Behavioral Therapy and Nicotine Replacement Therapy for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01842334
- Acronym / sponsor ID
- DCS / 2012P001707
- Conditions
- Nicotine Dependence, Smoking Cessation
- Keywords
- Nicotine Dependence, Smoking Cessation, D-cycloserine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: left institution protocol closed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- American Lung Association
- Study start
- Apr 2013 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Posted 1 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Compare the relative efficacy of ten weeks of once weekly 250 mg D-cycloserine (DCS) vs. placebo (both in conjunction with cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT) on reducing cigarette smoking in treatment-seeking nicotine-dependent outpatients.
- Compare the relative efficacy of ten weeks of once weekly 250 mg DCS vs. placebo on the process of extinction and the memory encoding process.
Detailed description
The investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to develop a medication to treat nicotine dependence. In a randomized, double-blind, placebo-controlled trial, 40 nicotine-dependent participants ages 18-65 will receive cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT) over a 10- week period, with half receiving D-cycloserine (DCS) pretreatment and half receiving placebo. Participants will receive either 250 mg DCS or placebo prior to weekly CBT sessions in addition to NRT over a 10-week treatment period. The investigators also aim to determine the effects of DCS on performance on neuropsychological tests. A 10-week treatment period will be followed by follow-up assessments including neuropsychological tests at 1 and 3 months post-treatment. Primary outcomes will include smoking as measured by carbon monoxide levels and self-report measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-cycloserine | Experimental | Behavioral: Cognitive Behavioral Therapy, Drug: Nicotine Replacement Therapy250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy. |
| Placebo | Placebo comparator | Behavioral: Cognitive Behavioral Therapy, Drug: Nicotine Replacement Therapyone placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Age range 18-65 years; 2) DSM-IV diagnosis of nicotine dependence, based on the Structured Clinical Interview for DSM-IV (SCID) (First et al. 1996); 3) express a desire to quit cigarette smoking within the next 30 days; 4) smokes greater than or equal to 10 cigarettes per day and less than or equal to 20 cigarettes per day; 5) an expired carbon monoxide (CO) determination greater than or equal to 10 ppm over ambient values; 6) for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and multiple subsequent pregnancy tests; 7) consent for us to communicate with their prescribing clinician; 8) furnish the names of 2 locators, who would assist study staff in locating them during the study period; 9) live close enough to McLean Hospital to attend study visits; 10) plan to remain in the Boston area for the next 4 months; and 11) are willing and able to sign informed consent.
Key exclusion criteria (1 listed)
- 1) Current diagnosis of other drug or alcohol dependence (other than nicotine); 2) significant cardiac disease; 3) current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder (taking psychiatric medications, aside from wellbutrin, is not an exclusionary criterion); 4) have a current medical condition (including significant laboratory abnormalities, such as liver function tests >5 times the upper limit of normal range) that could prevent regular study attendance; 5) have mental retardation or organic mental disorder; 6) exhibit acutely dangerous or suicidal behavior; 7) are pregnant, nursing, or, if a woman of childbearing potential, not using a form of birth control judged by the Principal Investigator to be effective; 8) current NRT or other smoking cessation treatment;9) current CBT for smoking cessation; 10) current smokeless tobacco use; 11) inability to read or write in English;12) has epilepsy.
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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBTCBT administered to to both DCS and placebo group. | Behavioural | D-cycloserine, Placebo |
| Nicotine Replacement TherapyAlso: NRTNRT administered to both DCS and placebo group. | Drug | D-cycloserine, Placebo |
Primary outcome
Change From Baseline in Cigarette Smoking in Treatment Seeking Nicotine Dependent Outpatients
Time frame: During Week 10
Cigarette smoking at 10 weeks as measured by carbon monoxide levels and self-report measurements.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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.
Kevin P. Hill, MD, MHS principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive Behavioral Therapy and Nicotine Replacement Therapy in people with Nicotine Dependence and Smoking Cessation, run by Mclean 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 31 Aug 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 1 Aug 2018). 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?
Change From Baseline in Cigarette Smoking in Treatment Seeking Nicotine Dependent Outpatients (time frame: During Week 10). 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 31 Aug 2018.