Nicotine DependenceNCT01859364
Tobacco Cessation: Treatment Delivery and Predictors of Outcome
An observational study of Nicotine Dependence, run by National Institute on Drug Abuse (NIDA).
Trial summary
Background: The success rate for those who attempt to quit using tobacco products is only about 5 percent. Many people who try to quit do so without seeking professional help. Several kinds of nicotine replacement therapy (NRT) are available without a prescription. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2013to 1 Mar 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Seeking help for cessation of tobacco use
Who cannot join
- Inability to give informed consent.
- Current use (within the past 30 days) of any of the 7 FDA-approved first-line smoking-cessation treatments (varenicline, bupropion, or NRTs such as a nicotine inhaler, lozenge, patch, gum, or nasal spray), unless administered as part of another NIDA IRP protocol.
- Any newly diagnosed or untreated acute medical illness that requires immediate medical attention. This includes any new medical diagnosis (for example, diabetes or hypertension) in someone who is not under the care of a physician and/or that is not well controlled. An untreated acute medical illness would include acute hepatitis, acute pancreatitis, acute respiratory distress syndrome, etc. Individuals may be considered for participation once a newly diagnosed condition is well controlled or an acute condition has resolved.
- ADDITIONAL EXCLUSION FOR NRT:
- Current major medical conditions that in the view of the investigators would compromise the integrity of the data or the safety of the participant, including moderate to severe cardiovascular disease (30 days post-MI, severe or worsening angina pectoris), life-threatening arrhythmias, acute phase cerebrovascular accident, COPD (emphysema and chronic bronchitis).
- Current uncontrolled psychiatric condition that in the view of the investigators would compromise the integrity of the data or the safety of the participant, including bipolar disorders and any psychotic disorder. Uncontrolled psychiatric condition includes but is not limited to: psychiatric medication change in the last 3 months; or psychiatric exacerbation or related hospitalization in the last 3 months. Individuals with controlled Major Depressive Disorder under the care of a psychiatrist or internist may be considered for inclusion.
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- Pregnancy
- Lab values outside of the values listed in Table 1 below.
- Nicotine patch only: allergy to adhesive tape, generalized chronic dermatological disorders, weight <45kg, and/or lactation
- ADDITIONAL EXCLUSION CRITERIA FOR VARENICLINE OR BUPROPION:
- Pregnancy or nursing
- Current diagnosis of schizophrenia or any other DSM-IV psychotic disorder, bipolar disorder, panic disorder, eating disorder (current or prior diagnoses), Major Depressive Disorder within the past year requiring treatment, or history of suicide attempt
- History of seizures, except for febrile seizures in childhood
- Current physical dependence on alcohol or sedative-hypnotics, e.g. benzodiazepines
- Lab values outside of the values listed in Table 1 below
- Unstable cardiovascular disease or cardiovascular events occurring within two months before screening
- For bupropion only: current administration of monoamine oxidase inhibitors (MAO-I); at least 14 days must elapse between discontinuation of an MAO-I and initiation of treatment with bupropion; current administration (within past 30 days) Wellbutrin, Wellbutrin SR, Wellbutrin XL.
About this study
Official title: Tobacco Cessation:Treatment Delivery and Predictors of Outcome
Background:
- The success rate for those who attempt to quit using tobacco products is only about 5 percent. Many people who try to quit do so without seeking professional help. Several kinds of nicotine replacement therapy (NRT) are available without a prescription. However, prescription drugs and mental health counseling can also help people stop using tobacco. Combining NRT and/or medication with counseling can increase success rates. Researchers want to study what kinds of tobacco cessation treatments are most successful. This may help develop better treatments and determine who will respond best to them.
Read more
Objectives:
- To provide treatment for tobacco use.
- To identify factors that affect how well people respond to treatment.
Eligibility:
- Individuals at least 18 years of age who are trying to stop using tobacco products.
Design:
- This study will last up to 1 year. Treatment may last up to 36 weeks. Treatment may include counseling, NRT (patches and/or nicotine lozenges), or prescription medication (varenicline or bupropion). Treatment will be determined by a study doctor.
- Participants will also have three study visits at 4, 6, and 12 months after starting treatment. Each visit may take up to 2 hours. At the study visits, participants will have different kinds of tests. They will provide blood and urine samples, and have carbon monoxide breath tests. They will also fill out forms about mood and tobacco cravings.
- During treatment, participants will have clinic visits once or twice a week for counseling and to monitor tobacco use and withdrawal symptoms. Counseling sessions will work on dealing with tobacco cravings. Each visit may take up to 90 minutes.
Read the detailed description
Objective
The purpose of this protocol is to create a mechanism whereby the intramural program of the NIDA in Baltimore, MD can evaluate and treat a broad range of people who use tobacco products. Through this protocol, participants will receive state-of-the-art treatment for their tobacco use. The secondary objective is to investigate predictors of success in tobacco-use-cessation treatment.
Study population
Participants will be individuals who present to the NIDA IRP seeking to quit tobacco use (smoked and smokeless). Enrollment may occur as part of participation in another NIDA IRP study. We will enroll up to 1000 participants. All individuals who give signed informed consent and who attend at least one study visit will be considered evaluable. We will not replace study dropouts.
Design
After undergoing initial screening and signing the IRB-approved consent form, participants will be enrolled in our outpatient smoking treatment-research clinic at the NIDA IRP. The study will last up to one year, with active treatment lasting up to 36 weeks and follow-up visits 4, 6, and 12 months after the first treatment visit. Treatment will include counseling and pharmacotherapy (nicotine replacement, bupropion, or varenicline, if warranted and medically appropriate). During active treatment, participants will visit the clinic up to twice a week for counseling, dispensing of medication, and monitoring of tobacco use, withdrawal symptoms, and reporting of any adverse events. Visits may take up to 90 minutes.
Outcome measures
There are no outcome measures for the primary objective. For the secondary objectives, the outcome measures are (1) tobacco abstinence, as determined by self-reported tobacco use, urinary cotinine, and (in tobacco smokers only) breath CO, and (2) reduction in tobacco use of at least 50% (e.g., from 10 cigarettes per day to 5 cigarettes per day). Other outcome measures for the secondary objectives include duration of abstinence, nicotine withdrawal signs and symptoms, and tobacco craving. Behavioral, psychological, medical, and genetic characteristics and tobacco-use history will be assessed at the beginning of the study as predictors of treatment outcome and at follow-up.
- Conditions
- Nicotine Dependence
- Keywords
- Tobacco, Smoking, Smoking Cessation, Outcome, Nicotine Dependence
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco abstinence, defined as no tobacco use by any measure (self-report, urine cotinine, and breath CO) during the assessment period.
Measured: prospective
A reduction in tobacco use of at least 50% (e.g., from 10 cigarettes per day to 5 cigarettes per day).
Measured: prospective
Secondary outcomes (1)
Nicotine withdrawal signs and symptoms and tobacco craving (VAS) during treatment and at follow-up; duration of continuous abstinence from tobacco (self-report) and 7-day point prevalence smoking abstinence rates at follow-up time points.
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study start27 Apr 2013
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Carol Myers, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859364
- Sponsor's protocol ID
- 999913484
- Other IDs
- 13-DA-N484
- Status last verified
- 8 Jul 2014
- First submitted
- 17 May 2013
- Last updated
- 14 Feb 2018
- Results posted
- No
Publications
Allsworth JE, Weitzen S, Boardman LA. Early age at menarche and allostatic load: data from the Third National Health and Nutrition Examination Survey. Ann Epidemiol. 2005 Jul;15(6):438-44. doi: 10.1016/j.annepidem.2004.12.010.
PubMed 15967391Baker A, Lewin T, Reichler H, Clancy R, Carr V, Garrett R, Sly K, Devir H, Terry M. Motivational interviewing among psychiatric in-patients with substance use disorders. Acta Psychiatr Scand. 2002 Sep;106(3):233-40. doi: 10.1034/j.1600-0447.2002.01118.x.
PubMed 12197863Bernstein DP, Fink L, Handelsman L, Foote J, Lovejoy M, Wenzel K, Sapareto E, Ruggiero J. Initial reliability and validity of a new retrospective measure of child abuse and neglect. Am J Psychiatry. 1994 Aug;151(8):1132-6. doi: 10.1176/ajp.151.8.1132.
PubMed 8037246
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Cessation:Treatment Delivery and Predictors of Outcome
- ClinicalTrials.gov ID
- NCT01859364
- Acronym / sponsor ID
- 999913484
- Conditions
- Nicotine Dependence
- Keywords
- Tobacco, Smoking, Smoking Cessation, Outcome, Nicotine Dependence
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 27 Apr 2013
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 21 May 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.
Background:
- The success rate for those who attempt to quit using tobacco products is only about 5 percent. Many people who try to quit do so without seeking professional help. Several kinds of nicotine replacement therapy (NRT) are available without a prescription. However, prescription drugs and mental health counseling can also help people stop using tobacco. Combining NRT and/or medication with counseling can increase success rates. Researchers want to study what kinds of tobacco cessation treatments are most successful. This may help develop better treatments and determine who will respond best to them.
Objectives:
- To provide treatment for tobacco use.
- To identify factors that affect how well people respond to treatment.
Eligibility:
- Individuals at least 18 years of age who are trying to stop using tobacco products.
Design:
- This study will last up to 1 year. Treatment may last up to 36 weeks. Treatment may include counseling, NRT (patches and/or nicotine lozenges), or prescription medication (varenicline or bupropion). Treatment will be determined by a study doctor.
- Participants will also have three study visits at 4, 6, and 12 months after starting treatment. Each visit may take up to 2 hours. At the study visits, participants will have different kinds of tests. They will provide blood and urine samples, and have carbon monoxide breath tests. They will also fill out forms about mood and tobacco cravings.
- During treatment, participants will have clinic visits once or twice a week for counseling and to monitor tobacco use and withdrawal symptoms. Counseling sessions will work on dealing with tobacco cravings. Each visit may take up to 90 minutes.
Detailed description
Objective
The purpose of this protocol is to create a mechanism whereby the intramural program of the NIDA in Baltimore, MD can evaluate and treat a broad range of people who use tobacco products. Through this protocol, participants will receive state-of-the-art treatment for their tobacco use. The secondary objective is to investigate predictors of success in tobacco-use-cessation treatment.
Study population
Participants will be individuals who present to the NIDA IRP seeking to quit tobacco use (smoked and smokeless). Enrollment may occur as part of participation in another NIDA IRP study. We will enroll up to 1000 participants. All individuals who give signed informed consent and who attend at least one study visit will be considered evaluable. We will not replace study dropouts.
Design
After undergoing initial screening and signing the IRB-approved consent form, participants will be enrolled in our outpatient smoking treatment-research clinic at the NIDA IRP. The study will last up to one year, with active treatment lasting up to 36 weeks and follow-up visits 4, 6, and 12 months after the first treatment visit. Treatment will include counseling and pharmacotherapy (nicotine replacement, bupropion, or varenicline, if warranted and medically appropriate). During active treatment, participants will visit the clinic up to twice a week for counseling, dispensing of medication, and monitoring of tobacco use, withdrawal symptoms, and reporting of any adverse events. Visits may take up to 90 minutes.
Outcome measures
There are no outcome measures for the primary objective. For the secondary objectives, the outcome measures are (1) tobacco abstinence, as determined by self-reported tobacco use, urinary cotinine, and (in tobacco smokers only) breath CO, and (2) reduction in tobacco use of at least 50% (e.g., from 10 cigarettes per day to 5 cigarettes per day). Other outcome measures for the secondary objectives include duration of abstinence, nicotine withdrawal signs and symptoms, and tobacco craving. Behavioral, psychological, medical, and genetic characteristics and tobacco-use history will be assessed at the beginning of the study as predictors of treatment outcome and at follow-up.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Seeking help for cessation of tobacco use
Key exclusion criteria (17 listed)
- Inability to give informed consent.
- Current use (within the past 30 days) of any of the 7 FDA-approved first-line smoking-cessation treatments (varenicline, bupropion, or NRTs such as a nicotine inhaler, lozenge, patch, gum, or nasal spray), unless administered as part of another NIDA IRP protocol.
- Any newly diagnosed or untreated acute medical illness that requires immediate medical attention. This includes any new medical diagnosis (for example, diabetes or hypertension) in someone who is not under the care of a physician and/or that is not well controlled. An untreated acute medical illness would include acute hepatitis, acute pancreatitis, acute respiratory distress syndrome, etc. Individuals may be considered for participation once a newly diagnosed condition is well controlled or an acute condition has resolved.
- Current major medical conditions that in the view of the investigators would compromise the integrity of the data or the safety of the participant, including moderate to severe cardiovascular disease (30 days post-MI, severe or worsening angina pectoris), life-threatening arrhythmias, acute phase cerebrovascular accident, COPD (emphysema and chronic bronchitis).
- Current uncontrolled psychiatric condition that in the view of the investigators would compromise the integrity of the data or the safety of the participant, including bipolar disorders and any psychotic disorder. Uncontrolled psychiatric condition includes but is not limited to: psychiatric medication change in the last 3 months; or psychiatric exacerbation or related hospitalization in the last 3 months. Individuals with controlled Major Depressive Disorder under the care of a psychiatrist or internist may be considered for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tobacco abstinence, defined as no tobacco use by any measure (self-report, urine cotinine, and breath CO) during the assessment period.
Time frame: prospective
A reduction in tobacco use of at least 50% (e.g., from 10 cigarettes per day to 5 cigarettes per day).
Time frame: prospective
1 secondary outcome
Nicotine withdrawal signs and symptoms and tobacco craving (VAS) during treatment and at follow-up; duration of continuous abstinence from tobacco (self-report) and 7-day point prevalence smoking abstinence rates at follow-up time points.
Time frame: prospective
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 14 Feb 2018.
- Background: PubMed 15967391Allsworth JE, Weitzen S, Boardman LA. Early age at menarche and allostatic load: data from the Third National Health and Nutrition Examination Survey. Ann Epidemiol. 2005 Jul;15(6):438-44. doi: 10.1016/j.annepidem.2004.12.010.
- Background: PubMed 12197863Baker A, Lewin T, Reichler H, Clancy R, Carr V, Garrett R, Sly K, Devir H, Terry M. Motivational interviewing among psychiatric in-patients with substance use disorders. Acta Psychiatr Scand. 2002 Sep;106(3):233-40. doi: 10.1034/j.1600-0447.2002.01118.x.
- Background: PubMed 8037246Bernstein DP, Fink L, Handelsman L, Foote J, Lovejoy M, Wenzel K, Sapareto E, Ruggiero J. Initial reliability and validity of a new retrospective measure of child abuse and neglect. Am J Psychiatry. 1994 Aug;151(8):1132-6. doi: 10.1176/ajp.151.8.1132.
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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.
Carol Myers, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Dependence, run by National Institute on Drug Abuse (NIDA).
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 2 inclusion and 17 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Tobacco abstinence, defined as no tobacco use by any measure (self-report, urine cotinine, and breath CO) during the assessment period. (time frame: prospective). 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?
On the ClinicalTrials.gov record for NCT01859364, which also lists 3 linked publications.
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 14 Feb 2018.