Cigarette SmokingPhase 2NCT01907594
Effects of Nicotine Replacement Therapy and D-cycloserine on Nicotine Treatment Seekers
A Phase 2 study testing D-cycloserine, Nicotine Replacement Therapy (patch) and Smoking Cue Exposure in people with Cigarette Smoking, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The investigators previously developed a cigarette cue extinction treatment (CET) procedure in non-treatment seeking volunteer smokers in our nicotine laboratory. The goal of Cue Extinction Treatment is to un-pair a behavioral or autonomic response from the stimulus that triggers it. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- D-cycloserine, Nicotine Replacement Therapy (patch) and Smoking Cue Exposure
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2016
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Seeking treatment for nicotine dependence
- Medically healthy on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests, with a negative pregnancy test for females.
- A DSM-IV diagnosis of nicotine dependence with physiological dependence. Has smoked at least 15 cigarettes daily for at least two years.
- Able to perform study procedures.
- Males or females between the ages of 21-55 yrs.
- Female Participants agree to use an effective method of birth control
Who cannot join
- A DSM-IV diagnosis of lifetime history of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications (within last three months).
- Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders.
- Participants on parole or probation
- History of significant recent violent behavior, e.g., one or more incidents of violent behavior in the past year resulting in physical damage.
- Unstable medical condition, Blood pressure > 140/90, Pregnancy.
Show all 10Show fewer
- History of allergic reaction to nicotine patch.
- History of hypersensitivity to cycloserine.
- Any history of seizures
- History of renal disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
The investigators previously developed a cigarette cue extinction treatment (CET) procedure in non-treatment seeking volunteer smokers in our nicotine laboratory. The goal of Cue Extinction Treatment is to un-pair a behavioral or autonomic response from the stimulus that triggers it. This is accomplished through repeated exposure to that trigger, while removing the patient's ability to act out the conditioned response. In the present study, the trigger is a lit cigarette, and the response the investigators seek to un-pair is cigarette craving. In the procedure the investigators have previously developed and intend to use again, the participant is shown a pack of his brand of choice cigarettes. The researcher removes a cigarette from the pack, lights it, and asks the participant to hold the cigarette without smoking it for 90 seconds. This procedure is repeated seven times over the course of a six-hour lab session. The investigators hope to boost the clinical response to smoking cue exposure therapy in quitters on NRT (nicotine replacement therapy) pretreatment by pharmacological augmentation with the partial NMDA receptor agonist D-cycloserine (DCS). Behavioral extinction training is a form of learning that may be modulated by NMDA receptor mediated glutamate transmission. The study's main hypothesis is that the partial NMDA receptor agonist D-cycloserine (DCS) facilitates cue exposure training and may prevent relapse to smoking. The aim of the proposed study is to assess whether DCS-facilitation of cue-exposure therapy improves abstinence among smokers on the nicotine patch seeking treatment. Development of an effective treatment strategy to enhance the effectiveness of NRTs would have a direct and significant positive impact on public health.
- Conditions
- Cigarette Smoking
- Being tested
- D-cycloserine, Nicotine Replacement Therapy (patch), Smoking Cue Exposure, Progressive Muscle Relaxation, Placebo
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
Nicotine Replacement Therapy (patch)Drug
Smoking Cue ExposureBehavioural
Progressive Muscle RelaxationBehavioural
PlaceboDrug
The investigators will administer Gelatin Capsule instead of D-Cycloserine in a double blind fashion to some of study subjects.
| Study group | Role | What they receive |
|---|---|---|
| D-cycloserine | Active comparator | The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days. Receives: Drug: D-cycloserine; Drug: Nicotine Replacement Therapy (patch); Behavioral: Smoking Cue Exposure; Behavioral: Progressive Muscle Relaxation |
| Gelatin Capsule | Placebo comparator | The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days. Receives: Drug: Nicotine Replacement Therapy (patch); Behavioral: Smoking Cue Exposure; Behavioral: Progressive Muscle Relaxation; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cigarettes Smoked
Smoking Diary kept of daily cigarette smoking.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2015
- Study completionSep 2016
Why it stopped: Ran out of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S. Rob Vorel, New York State Psychiatric Institute
- Investigators
- S. Rob Vorel, MD, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907594
- Sponsor's protocol ID
- 6769
- Status last verified
- Oct 2020
- First submitted
- 10 Jul 2013
- Last updated
- 8 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotine Replacement Therapy and D-cycloserine on Nicotine Treatment Seekers
- ClinicalTrials.gov ID
- NCT01907594
- Acronym / sponsor ID
- 6769
- Conditions
- Cigarette Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ran out of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Jul 2013 (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.
The investigators previously developed a cigarette cue extinction treatment (CET) procedure in non-treatment seeking volunteer smokers in our nicotine laboratory. The goal of Cue Extinction Treatment is to un-pair a behavioral or autonomic response from the stimulus that triggers it. This is accomplished through repeated exposure to that trigger, while removing the patient's ability to act out the conditioned response. In the present study, the trigger is a lit cigarette, and the response the investigators seek to un-pair is cigarette craving. In the procedure the investigators have previously developed and intend to use again, the participant is shown a pack of his brand of choice cigarettes. The researcher removes a cigarette from the pack, lights it, and asks the participant to hold the cigarette without smoking it for 90 seconds. This procedure is repeated seven times over the course of a six-hour lab session. The investigators hope to boost the clinical response to smoking cue exposure therapy in quitters on NRT (nicotine replacement therapy) pretreatment by pharmacological augmentation with the partial NMDA receptor agonist D-cycloserine (DCS). Behavioral extinction training is a form of learning that may be modulated by NMDA receptor mediated glutamate transmission. The study's main hypothesis is that the partial NMDA receptor agonist D-cycloserine (DCS) facilitates cue exposure training and may prevent relapse to smoking. The aim of the proposed study is to assess whether DCS-facilitation of cue-exposure therapy improves abstinence among smokers on the nicotine patch seeking treatment. Development of an effective treatment strategy to enhance the effectiveness of NRTs would have a direct and significant positive impact on public health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-cycloserine | Active comparator | Drug: D-cycloserine, Drug: Nicotine Replacement Therapy (patch), Behavioral: Smoking Cue Exposure, Behavioral: Progressive Muscle RelaxationThe investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days. |
| Gelatin Capsule | Placebo comparator | Drug: Nicotine Replacement Therapy (patch), Behavioral: Smoking Cue Exposure, Behavioral: Progressive Muscle Relaxation, Drug: PlaceboThe investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Seeking treatment for nicotine dependence
- Medically healthy on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests, with a negative pregnancy test for females.
- A DSM-IV diagnosis of nicotine dependence with physiological dependence. Has smoked at least 15 cigarettes daily for at least two years.
- Able to perform study procedures.
- Males or females between the ages of 21-55 yrs.
Key exclusion criteria (10 listed)
- A DSM-IV diagnosis of lifetime history of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications (within last three months).
- Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders.
- Participants on parole or probation
- History of significant recent violent behavior, e.g., one or more incidents of violent behavior in the past year resulting in physical damage.
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-cycloserine | Drug | D-cycloserine |
| Nicotine Replacement Therapy (patch) | Drug | D-cycloserine, Gelatin Capsule |
| Smoking Cue Exposure | Behavioural | D-cycloserine, Gelatin Capsule |
| Progressive Muscle Relaxation | Behavioural | D-cycloserine, Gelatin Capsule |
| PlaceboThe investigators will administer Gelatin Capsule instead of D-Cycloserine in a double blind fashion to some of study subjects. | Drug | Gelatin Capsule |
Primary outcome
Number of Cigarettes Smoked
Time frame: 3 months
Smoking Diary kept of daily cigarette smoking.
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 8 Oct 2020.
Related trials for Cigarette Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking
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.
S. Rob Vorel, MD, PhD principal investigator
New York State Psychiatric Institute
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, Nicotine Replacement Therapy (patch) and Smoking Cue Exposure in people with Cigarette Smoking, run by New York State Psychiatric Institute 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 6 inclusion and 10 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 8 Oct 2020. 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?
Number of Cigarettes Smoked (time frame: 3 months). 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 8 Oct 2020.