Tobacco Use DisorderEarly Phase 1NCT01329614
Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving
A Early Phase 1 study testing Cue Extinction Training, Nicotine Replacement Therapy and Cue Extinction Therapy in people with Tobacco Use Disorder, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Cue Extinction Training will reduce relapse rates in cigarette smokers using the patch to quit. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Cue Extinction Training, Nicotine Replacement Therapy and Cue Extinction Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2013
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A DSM-IV Diagnosis of nicotine dependence with physiological dependence. Smoke at least 15 cigarettes daily for two years.
- Not interested in treatment.
- Medically healthy on the basis of physical examination and medical history, vital signs, EKG and laboratory tests, with a negative pregnancy test for females.
- Able to perform study procedures.
- Males or females between the ages of 21-60 years.
- Female participants agree to use an effective method of birth control during the course of the study.
Who cannot join
- A DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine.
- Current Axis I diagnosis or current treatment with psychotropic medications (within last 3 months).
- Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders.
- Seeking treatment for nicotine dependence.
- Participants on parole or probation.
- History of significant recent violent behavior.
Show all 9Show fewer
- Unstable medical condition, Blood Pressure > 150/90, Pregnancy.
- History of allergic reaction to nicotine patch.
- Participants with significant cardiac history (i.e. angina pectoris, bypass surgery, or coronary artery disease.)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute - Substance Use Research Center
New York, New York, 10032
About this study
The purpose of this study is to determine whether Cue Extinction Training will reduce relapse rates in cigarette smokers using the patch to quit.
Read the detailed description
Nicotine dependence is an important public health problem that contributes to significant morbidity and mortality in our society. Treatment efforts are hampered by high relapse rates, despite the development of somewhat effective treatment modalities, such as Nicotine Replacement Treatment (NRT). NRT, e.g. the nicotine patch, is successful in smoking cessation, compensating for nicotine withdrawal after quitting smoking.
However, relapse rates remain high even in quitters on the patch. It is thought that cravings related to smoking cues contribute to relapse in smokers on the patch who try to quit. Rational treatment approaches for nicotine dependence therefore include strategies to weaken the effect of smoking cues, e.g. cue extinction training (CET). During CET smokers are repeatedly exposed to smoking cues, in the absence of nicotine administration, and smokers report lessening of cue-induced craving (extinction). It is thought that the extinction of smoking cues will result in less control of the smoking cue over smoking behavior and lower relapse rates.
The investigators hypothesize that smoking quit rates on the patch will be higher after CET. To address our hypothesis the investigators first want to develop a proof of concept procedure that demonstrates that repeated cue exposure in the laboratory results in the lessening or 'extinction' of cue-induced craving. In addition, the investigators are interested in the contribution of nicotine withdrawal to cue-induced craving. To this end, the investigators propose to include a control group without nicotine replacement (i.e. placebo patch) that will also undergo the repeated cue exposure procedure.
This study will assess the effect of CET on subsequent craving triggered by smoking cues in cigarette-smoking volunteers. After overnight abstinence, participants will come into the lab, receive a patch (nicotine or placebo) and undergo the CET procedure and perform computer tests and fill out questionnaires.
The main goal of this project is to study the relationship between nicotine replacement, cue-extinction training and subsequent cue-induced craving. Showing the effectiveness of cue-extinction training in the proposed laboratory model will support the application of the cue-extinction procedure to improve relapse rates of nicotine replacement therapies in future clinical trials.
- Conditions
- Tobacco Use Disorder
- Being tested
- Cue Extinction Training, Nicotine Replacement Therapy, Cue Extinction Therapy, Progressive Muscle Relaxation
- Keywords
- Tobacco, Nicotine, Cigarette
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue Extinction TrainingBehavioural
Repeated exposure to cigarette cues while receiving Nicotine Replacement Therapy.
Nicotine Replacement TherapyDrug
Also called Nicoderm CQ
Study doctor applies a nicotine patch to the participant's shoulder blade. The patch dose is blinded by placement of a Bandaid over the patch itself.
Cue Extinction TherapyBehavioural
Participant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use.
Progressive Muscle RelaxationBehavioural
Participant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Replacement Therapy, 7mg dose | Experimental | Not described Receives: Behavioral: Cue Extinction Training; Drug: Nicotine Replacement Therapy; Behavioral: Cue Extinction Therapy; Behavioral: Progressive Muscle Relaxation |
| Nicotine Replacement Therapy, 21mg dose | Experimental | Not described Receives: Behavioral: Cue Extinction Training; Drug: Nicotine Replacement Therapy; Behavioral: Cue Extinction Therapy; Behavioral: Progressive Muscle Relaxation |
| Nicotine Replacement Therapy, Placebo | Placebo comparator | Not described Receives: Behavioral: Cue Extinction Training; Behavioral: Cue Extinction Therapy; Behavioral: Progressive Muscle Relaxation |
| Nicotine Replacement Therapy, 42mg dose | Experimental | Not described Receives: Behavioral: Cue Extinction Training; Drug: Nicotine Replacement Therapy; Behavioral: Cue Extinction Therapy; Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galvanic Skin Response
Measurements of Galvanic Skin Response (GSR) are taken while participant is exposed to the cue. The amount of change in GSR is used to determine CET's impact on cigarette craving.
Measured: 3 days, over the course of 4-5 weeks total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startOct 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- S. Rob Vorel, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329614
- Sponsor's protocol ID
- 6001
- Other IDs
- K23DA025735
- Status last verified
- Mar 2024
- First submitted
- 14 Oct 2010
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving
- ClinicalTrials.gov ID
- NCT01329614
- Acronym / sponsor ID
- 6001
- Conditions
- Tobacco Use Disorder
- Keywords
- Tobacco, Nicotine, Cigarette
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Apr 2011 (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 purpose of this study is to determine whether Cue Extinction Training will reduce relapse rates in cigarette smokers using the patch to quit.
Detailed description
Nicotine dependence is an important public health problem that contributes to significant morbidity and mortality in our society. Treatment efforts are hampered by high relapse rates, despite the development of somewhat effective treatment modalities, such as Nicotine Replacement Treatment (NRT). NRT, e.g. the nicotine patch, is successful in smoking cessation, compensating for nicotine withdrawal after quitting smoking.
However, relapse rates remain high even in quitters on the patch. It is thought that cravings related to smoking cues contribute to relapse in smokers on the patch who try to quit. Rational treatment approaches for nicotine dependence therefore include strategies to weaken the effect of smoking cues, e.g. cue extinction training (CET). During CET smokers are repeatedly exposed to smoking cues, in the absence of nicotine administration, and smokers report lessening of cue-induced craving (extinction). It is thought that the extinction of smoking cues will result in less control of the smoking cue over smoking behavior and lower relapse rates.
The investigators hypothesize that smoking quit rates on the patch will be higher after CET. To address our hypothesis the investigators first want to develop a proof of concept procedure that demonstrates that repeated cue exposure in the laboratory results in the lessening or 'extinction' of cue-induced craving. In addition, the investigators are interested in the contribution of nicotine withdrawal to cue-induced craving. To this end, the investigators propose to include a control group without nicotine replacement (i.e. placebo patch) that will also undergo the repeated cue exposure procedure.
This study will assess the effect of CET on subsequent craving triggered by smoking cues in cigarette-smoking volunteers. After overnight abstinence, participants will come into the lab, receive a patch (nicotine or placebo) and undergo the CET procedure and perform computer tests and fill out questionnaires.
The main goal of this project is to study the relationship between nicotine replacement, cue-extinction training and subsequent cue-induced craving. Showing the effectiveness of cue-extinction training in the proposed laboratory model will support the application of the cue-extinction procedure to improve relapse rates of nicotine replacement therapies in future clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Therapy, 7mg dose | Experimental | Behavioral: Cue Extinction Training, Drug: Nicotine Replacement Therapy, Behavioral: Cue Extinction Therapy, Behavioral: Progressive Muscle Relaxation |
| Nicotine Replacement Therapy, 21mg dose | Experimental | Behavioral: Cue Extinction Training, Drug: Nicotine Replacement Therapy, Behavioral: Cue Extinction Therapy, Behavioral: Progressive Muscle Relaxation |
| Nicotine Replacement Therapy, Placebo | Placebo comparator | Behavioral: Cue Extinction Training, Behavioral: Cue Extinction Therapy, Behavioral: Progressive Muscle Relaxation |
| Nicotine Replacement Therapy, 42mg dose | Experimental | Behavioral: Cue Extinction Training, Drug: Nicotine Replacement Therapy, Behavioral: Cue Extinction Therapy, Behavioral: Progressive Muscle Relaxation |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A DSM-IV Diagnosis of nicotine dependence with physiological dependence. Smoke at least 15 cigarettes daily for two years.
- Not interested in treatment.
- Medically healthy on the basis of physical examination and medical history, vital signs, EKG and laboratory tests, with a negative pregnancy test for females.
- Able to perform study procedures.
- Males or females between the ages of 21-60 years.
Key exclusion criteria (9 listed)
- A DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine.
- Current Axis I diagnosis or current treatment with psychotropic medications (within last 3 months).
- Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders.
- Seeking treatment for nicotine dependence.
- Participants on parole or probation.
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 |
|---|---|---|
| Cue Extinction TrainingRepeated exposure to cigarette cues while receiving Nicotine Replacement Therapy. | Behavioural | Nicotine Replacement Therapy, 21mg dose, Nicotine Replacement Therapy, 42mg dose, Nicotine Replacement Therapy, 7mg dose, Nicotine Replacement Therapy, Placebo |
| Nicotine Replacement TherapyAlso: Nicoderm CQStudy doctor applies a nicotine patch to the participant's shoulder blade. The patch dose is blinded by placement of a Bandaid over the patch itself. | Drug | Nicotine Replacement Therapy, 21mg dose, Nicotine Replacement Therapy, 42mg dose, Nicotine Replacement Therapy, 7mg dose |
| Cue Extinction TherapyParticipant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use. | Behavioural | Nicotine Replacement Therapy, 21mg dose, Nicotine Replacement Therapy, 42mg dose, Nicotine Replacement Therapy, 7mg dose, Nicotine Replacement Therapy, Placebo |
| Progressive Muscle RelaxationParticipant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques. | Behavioural | Nicotine Replacement Therapy, 21mg dose, Nicotine Replacement Therapy, 42mg dose, Nicotine Replacement Therapy, 7mg dose, Nicotine Replacement Therapy, Placebo |
Primary outcome
Galvanic Skin Response
Time frame: 3 days, over the course of 4-5 weeks total.
Measurements of Galvanic Skin Response (GSR) are taken while participant is exposed to the cue. The amount of change in GSR is used to determine CET's impact on cigarette craving.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Related trials for Tobacco Use Disorder
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
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
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cue Extinction Training, Nicotine Replacement Therapy and Cue Extinction Therapy in people with Tobacco Use Disorder, run by Columbia University 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 9 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 15 Mar 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Galvanic Skin Response (time frame: 3 days, over the course of 4-5 weeks total.). 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 15 Mar 2024.