Cigarette SmokingPhase 1ADQUITNCT02266784
Contingency Management, Quitting Smoking, and ADHD
A Phase 1 study testing Contingency Management (CM), Transdermal nicotine skin patches (i.e. Habitrol) and Supportive Counseling in people with Cigarette Smoking and Smoking Cessation, run by Duke University at 1 site in United States.
Trial summary
The overall goal of the study is to evaluate how motivation and readiness for change are influenced in the context of a smoking cessation attempt. A total of 60 adult (i.e. age 18-55) smokers (N=40 with ADHD; N=20 without ADHD) who are interested in quitting will be enrolled into a 3-arm trial allocated as follows. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Smoking Cessation
- What is being tested?
- Contingency Management (CM), Transdermal nicotine skin patches (i.e. Habitrol) and Supportive Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 8 Dec 2017
- Phase
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years of age
- Male or female; if female of child-bearing potential, must be using an acceptable form of contraception
- ADHD Diagnosis:
- For ADHD Groups: confirmed primary diagnosis, any subtype as determined by the clinician administered CAADID and clinical interview
- For Control Group: NO diagnosis of ADHD as determined by clinician administered CAADID and clinical interview
- ADHD Symptom Ratings:
Show all 11Show fewer
- For ADHD Groups: T-Score > 65 on one of the DSM-IV relevant scales (Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index) on both the Self-Report and Observer versions of the CAARS
- For Control Group: T-Score < 60 on all of the DSM-IV relevant scales (Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index) on both the Self-Report and Observer versions of the CAARS
- Self-report smoking at least 10 cigarettes/day
- Provides an afternoon exhaled carbon monoxide reading of at least 10 ppm.
- Cognitive functioning > 80 as assessed by the KBIT-II
Who cannot join
- History of chronic/significant medical condition
- Use of any psychoactive medication in the past 12 months, other than FDA-approved medication for the ADHD group only
- Estimated IQ < 80 on Kaufmann Brief Intelligence Test, Second Edition
- Has a primary diagnosis of any other Axis I Disorder (determined by the Structured Diagnostic Interview for DSM; SCID) that is significantly impairing and would contraindicate participation in the present study
- Has a primary diagnosis of any Axis II Disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Child and Family Study Center
Durham, North Carolina, 27705
About this study
Official title: Smoking/Nicotine Dependence in Attention Deficit Hyperactivity Disorder (ADHD)
The overall goal of the study is to evaluate how motivation and readiness for change are influenced in the context of a smoking cessation attempt. A total of 60 adult (i.e. age 18-55) smokers (N=40 with ADHD; N=20 without ADHD) who are interested in quitting will be enrolled into a 3-arm trial allocated as follows. Twenty of the ADHD smokers and the 20 non-ADHD smokers will be assigned to a traditional 8-week contingency management intervention in which monetary payments will be made contingent upon biologically verified evidence of smoking abstinence. The 20 additional ADHD smokers will be assigned to a treatment-as-usual condition (nicotine replacement; supportive counseling). During the treatment phase, subjects will be required to answer questions 4x/week in their daily lives via an EMA (Ecological Momentary Assessment).
Specific Aim 1: To assess motivation to quit smoking and readiness for change prior to a quit attempt in treatment seeking ADHD and non-ADHD smokers. Hypothesis 1a: The investigators hypothesize that prior to a quit attempt, smokers with ADHD will exhibit significantly lower levels of intrinsic motivation to quit, and equal or higher levels of extrinsic motivation to quit compared to smokers without ADHD. Hypothesis 1b: The investigators hypothesize that smokers with ADHD will exhibit relatively less readiness for change than smokers without ADHD.
Read more
Specific Aim 2: To assess how baseline levels of motivation to quit and readiness for change are influenced during a quit attempt as a function of both ADHD status and treatment modality. Hypothesis 2a. The investigators hypothesize that the CM intervention will result in relatively greater change in extrinsic motivation to quit versus intrinsic motivation to quit, and that this effect will be more pronounced among ADHD smokers. Hypothesis 2b: The investigators hypothesize that overall motivation to quit (intrinsic and extrinsic) and readiness for change will be significantly influenced by the CM intervention versus treatment as usual among ADHD smokers.
Exploratory Aim 1: To assess the relative efficacy of a CM intervention versus treatment as usual in smokers with ADHD. The investigators hypothesize that CM will be more effective for promoting short-term (4-8 weeks) smoking abstinence, as well as for promoting longer-term (3-6 months) smoking cessation.
Exploratory Aim 2: To assess the associations among smoking withdrawal/craving, affect, ADHD symptoms, and motivation to quit/readiness for change. The investigators hypothesize that higher levels of motivation and readiness for change will be associated with lower levels of self-reported withdrawal, craving, and negative affect.
Read the detailed description
Individuals with ADHD have altered reinforcement/motivational functioning that are likely related to risk for smoking and recalcitrance for quitting. The investigators lab has demonstrated that the abstinence-induced reinforcing effects of cigarette smoking are more pronounced in ADHD smokers. However, in spite of these increases and demonstrated differences in withdrawal severity, interventions that provide reinforcement contingent on abstinence appear to work well for smokers with ADHD. To date, no studies have explicitly investigated how motivational processes are associated with smoking cessation attempts in ADHD smokers. The proposed pilot research is therefore highly innovative since it will evaluate how these processes change and influence outcomes during two different kinds of smoking cessation interventions. The project will also provide important pilot data on potential differences between ADHD and non-ADHD smokers in the context of a contingency management (CM) trial, which will help guide the development of more refined and targeted cessation interventions for this high risk group of smokers.
- Conditions
- Cigarette Smoking, Smoking Cessation
- Being tested
- Contingency Management (CM), Transdermal nicotine skin patches (i.e. Habitrol), Supportive Counseling
- Keywords
- smoking, smoking cessation, contingency management, ADHD
- Medical subject headings
- Cigarette Smoking, Smoking Cessation, Smoking, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency Management (CM)Behavioural
Transdermal nicotine skin patches (i.e. Habitrol)Drug
Supportive CounselingOther
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management (CM) | Experimental | ADHD (N=20) \& CTRL (N=20). Participants will earn compensation, based upon smoking abstinence via a Contingency Management (CM) system. This level of compensation will increase by the same amount each visit based upon abstinence. In addition, escalating bonus payments will be available for evidence of continued abstinence. The first 10 visits will be daily weekdays. The following 9 visits will be over three weeks. The final 3 treatment visits will occur weekly. The 2nd \& 3rd type visits CM payments will be based upon monitoring participants' cotinine levels. A missed visit or elevated CO level will lead to 1) no CM payment for that day; 2) resetting the contingencies such that the next CO sample that is below the criterion will result in payment equal to the first day. If there is a lapse, participants' contingencies will be reinstated at their previous highest level post 3 abstinent days. Also follow-up visits at 3 and 6 months. Receives: Behavioral: Contingency Management (CM) |
| Treatment as Usual | Other | ADHD (N=20). Transdermal nicotine skin patches (i.e. Habitrol) will be used along with supportive counseling in the treatment as usual groups. Visit schedules will coincide with the visit schedules for the CM groups (daily visits for 1st 2 weeks, 3X weekly visits for weeks 3-5, 1x weekly visit for weeks 6-8). A standard regimen of nicotine replacement with which the study team has experience will be used: four weeks of 21 mg/d beginning on the QD, two weeks of 14 mg/d and two weeks of 7 mg/d. Also follow-up visits at 3 and 6 months. Receives: Drug: Transdermal nicotine skin patches (i.e. Habitrol); Other: Supportive Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motivation to quit smoking, as measured by the Readiness to Change Questionnaire
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Readiness to Change Questionnaire (RCQ) is a measure designed to assess attitudes toward quitting smoking.
Measured: Baseline to 9 weeks
Change in motivation to quit smoking, as measured by the Treatment Self-Regulation Questionnaire
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Treatment Self-Regulation Questionnaire measures autonomous motivation.
Measured: Baseline to 9 weeks
Change in motivation to quit smoking, as measured by the Perceived Competence Scale for Cessation
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Perceived Competence Scale for Cessation measures perceived competence to quit.
Measured: Baseline to 9 weeks
Change in motivation to quit smoking, as measured by the Reasons For Quitting questionnaire
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Reasons For Quitting questionnaire measures relative levels of intrinsic versus extrinsic motivation to quit smoking.
Measured: Baseline to 9 weeks
Change in readiness to change behavior, as measured by the Readiness to Change Questionnaire
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Readiness to Change Questionnaire (RCQ) is a measure designed to assess attitudes toward quitting smoking.
Measured: Baseline to 9 weeks
Change in readiness to change behavior, as measured by the Treatment Self-Regulation Questionnaire
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Treatment Self-Regulation Questionnaire measures autonomous motivation.
Measured: Baseline to 9 weeks
Change in readiness to change behavior, as measured by the Perceived Competence Scale for Cessation
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Perceived Competence Scale for Cessation measures perceived competence to quit.
Measured: Baseline to 9 weeks
Change in readiness to change behavior, as measured by the Reasons For Quitting questionnaire
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Reasons For Quitting questionnaire measures relative levels of intrinsic versus extrinsic motivation to quit smoking.
Measured: Baseline to 9 weeks
Comparison of populations in motivation to quit on the Reasons for Quitting Questionnaire
The study team will compare the change in scores for extrinsic and intrinsic motivation to quit on the Reasons for Quitting Questionnaire in the ADHD and non-ADHD groups assigned to receive CM.
Measured: Baseline to 9 weeks
Secondary outcomes (2)
Change in smoking behavior in ADHD population
This outcome is based both upon the treatment period and follow-up visits at 3 and 6 months. CM is proposed to be a potential more effective treatment in an ADHD population in the short and longer term, in comparison to treatment as usual. This will be measured by urine cotinine level and residual Carbon Monoxides levels from samples provided by participants.
Measured: Baseline, 3 months, 6 months
Decreasing effects of quitting smoking.
This outcome assesses overall whether increased motivation and readiness for behavior change (i.e. quit smoking), potentially associated CM, will decrease negative aspects of quitting. These include smoking withdrawal/craving, affect, and impact on ADHD symptoms.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
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.
- More trials run by Duke 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Scott H Kollins, Ph.D., Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266784
- Sponsor's protocol ID
- Pro00055228
- Other IDs
- 2K24DA023464-06A1
- Acronym
- ADQUIT
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2014
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking/Nicotine Dependence in Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02266784
- Acronym / sponsor ID
- ADQUIT / Pro00055228
- Conditions
- Cigarette Smoking, Smoking Cessation
- Keywords
- smoking, smoking cessation, contingency management, ADHD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2014
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 17 Oct 2014 (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 overall goal of the study is to evaluate how motivation and readiness for change are influenced in the context of a smoking cessation attempt. A total of 60 adult (i.e. age 18-55) smokers (N=40 with ADHD; N=20 without ADHD) who are interested in quitting will be enrolled into a 3-arm trial allocated as follows. Twenty of the ADHD smokers and the 20 non-ADHD smokers will be assigned to a traditional 8-week contingency management intervention in which monetary payments will be made contingent upon biologically verified evidence of smoking abstinence. The 20 additional ADHD smokers will be assigned to a treatment-as-usual condition (nicotine replacement; supportive counseling). During the treatment phase, subjects will be required to answer questions 4x/week in their daily lives via an EMA (Ecological Momentary Assessment).
Specific Aim 1: To assess motivation to quit smoking and readiness for change prior to a quit attempt in treatment seeking ADHD and non-ADHD smokers. Hypothesis 1a: The investigators hypothesize that prior to a quit attempt, smokers with ADHD will exhibit significantly lower levels of intrinsic motivation to quit, and equal or higher levels of extrinsic motivation to quit compared to smokers without ADHD. Hypothesis 1b: The investigators hypothesize that smokers with ADHD will exhibit relatively less readiness for change than smokers without ADHD.
Specific Aim 2: To assess how baseline levels of motivation to quit and readiness for change are influenced during a quit attempt as a function of both ADHD status and treatment modality. Hypothesis 2a. The investigators hypothesize that the CM intervention will result in relatively greater change in extrinsic motivation to quit versus intrinsic motivation to quit, and that this effect will be more pronounced among ADHD smokers. Hypothesis 2b: The investigators hypothesize that overall motivation to quit (intrinsic and extrinsic) and readiness for change will be significantly influenced by the CM intervention versus treatment as usual among ADHD smokers.
Exploratory Aim 1: To assess the relative efficacy of a CM intervention versus treatment as usual in smokers with ADHD. The investigators hypothesize that CM will be more effective for promoting short-term (4-8 weeks) smoking abstinence, as well as for promoting longer-term (3-6 months) smoking cessation.
Exploratory Aim 2: To assess the associations among smoking withdrawal/craving, affect, ADHD symptoms, and motivation to quit/readiness for change. The investigators hypothesize that higher levels of motivation and readiness for change will be associated with lower levels of self-reported withdrawal, craving, and negative affect.
Detailed description
Individuals with ADHD have altered reinforcement/motivational functioning that are likely related to risk for smoking and recalcitrance for quitting. The investigators lab has demonstrated that the abstinence-induced reinforcing effects of cigarette smoking are more pronounced in ADHD smokers. However, in spite of these increases and demonstrated differences in withdrawal severity, interventions that provide reinforcement contingent on abstinence appear to work well for smokers with ADHD. To date, no studies have explicitly investigated how motivational processes are associated with smoking cessation attempts in ADHD smokers. The proposed pilot research is therefore highly innovative since it will evaluate how these processes change and influence outcomes during two different kinds of smoking cessation interventions. The project will also provide important pilot data on potential differences between ADHD and non-ADHD smokers in the context of a contingency management (CM) trial, which will help guide the development of more refined and targeted cessation interventions for this high risk group of smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management (CM) | Experimental | Behavioral: Contingency Management (CM)ADHD (N=20) \& CTRL (N=20). Participants will earn compensation, based upon smoking abstinence via a Contingency Management (CM) system. This level of compensation will increase by the same amount each visit based upon abstinence. In addition, escalating bonus payments will be available for evidence of continued abstinence. The first 10 visits will be daily weekdays. The following 9 visits will be over three weeks. The final 3 treatment visits will occur weekly. The 2nd \& 3rd type visits CM payments will be based upon monitoring participants' cotinine levels. A missed visit or elevated CO level will lead to 1) no CM payment for that day; 2) resetting the contingencies such that the next CO sample that is below the criterion will result in payment equal to the first day. If there is a lapse, participants' contingencies will be reinstated at their previous highest level post 3 abstinent days. Also follow-up visits at 3 and 6 months. |
| Treatment as Usual | Other | Drug: Transdermal nicotine skin patches (i.e. Habitrol), Other: Supportive CounselingADHD (N=20). Transdermal nicotine skin patches (i.e. Habitrol) will be used along with supportive counseling in the treatment as usual groups. Visit schedules will coincide with the visit schedules for the CM groups (daily visits for 1st 2 weeks, 3X weekly visits for weeks 3-5, 1x weekly visit for weeks 6-8). A standard regimen of nicotine replacement with which the study team has experience will be used: four weeks of 21 mg/d beginning on the QD, two weeks of 14 mg/d and two weeks of 7 mg/d. Also follow-up visits at 3 and 6 months. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18-55 years of age
- Male or female; if female of child-bearing potential, must be using an acceptable form of contraception
- ADHD Diagnosis:
- For ADHD Groups: confirmed primary diagnosis, any subtype as determined by the clinician administered CAADID and clinical interview
- For Control Group: NO diagnosis of ADHD as determined by clinician administered CAADID and clinical interview
Key exclusion criteria (5 listed)
- History of chronic/significant medical condition
- Use of any psychoactive medication in the past 12 months, other than FDA-approved medication for the ADHD group only
- Estimated IQ < 80 on Kaufmann Brief Intelligence Test, Second Edition
- Has a primary diagnosis of any other Axis I Disorder (determined by the Structured Diagnostic Interview for DSM; SCID) that is significantly impairing and would contraindicate participation in the present study
- Has a primary diagnosis of any Axis II Disorder
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 |
|---|---|---|
| Contingency Management (CM) | Behavioural | Contingency Management (CM) |
| Transdermal nicotine skin patches (i.e. Habitrol) | Drug | Treatment as Usual |
| Supportive Counseling | Other | Treatment as Usual |
Primary outcome
Change in motivation to quit smoking, as measured by the Readiness to Change Questionnaire
Time frame: Baseline to 9 weeks
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Readiness to Change Questionnaire (RCQ) is a measure designed to assess attitudes toward quitting smoking.
Change in motivation to quit smoking, as measured by the Treatment Self-Regulation Questionnaire
Time frame: Baseline to 9 weeks
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Treatment Self-Regulation Questionnaire measures autonomous motivation.
Change in motivation to quit smoking, as measured by the Perceived Competence Scale for Cessation
Time frame: Baseline to 9 weeks
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Perceived Competence Scale for Cessation measures perceived competence to quit.
Change in motivation to quit smoking, as measured by the Reasons For Quitting questionnaire
Time frame: Baseline to 9 weeks
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Reasons For Quitting questionnaire measures relative levels of intrinsic versus extrinsic motivation to quit smoking.
Change in readiness to change behavior, as measured by the Readiness to Change Questionnaire
Time frame: Baseline to 9 weeks
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Readiness to Change Questionnaire (RCQ) is a measure designed to assess attitudes toward quitting smoking.
Change in readiness to change behavior, as measured by the Treatment Self-Regulation Questionnaire
Time frame: Baseline to 9 weeks
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Treatment Self-Regulation Questionnaire measures autonomous motivation.
Change in readiness to change behavior, as measured by the Perceived Competence Scale for Cessation
Time frame: Baseline to 9 weeks
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Perceived Competence Scale for Cessation measures perceived competence to quit.
Change in readiness to change behavior, as measured by the Reasons For Quitting questionnaire
Time frame: Baseline to 9 weeks
During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Reasons For Quitting questionnaire measures relative levels of intrinsic versus extrinsic motivation to quit smoking.
Comparison of populations in motivation to quit on the Reasons for Quitting Questionnaire
Time frame: Baseline to 9 weeks
The study team will compare the change in scores for extrinsic and intrinsic motivation to quit on the Reasons for Quitting Questionnaire in the ADHD and non-ADHD groups assigned to receive CM.
2 secondary outcomes
Change in smoking behavior in ADHD population
Time frame: Baseline, 3 months, 6 months
Decreasing effects of quitting smoking.
Time frame: Baseline, 3 months, 6 months
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 19 Oct 2020.
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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.
Scott H Kollins, Ph.D. principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Contingency Management (CM), Transdermal nicotine skin patches (i.e. Habitrol) and Supportive Counseling in people with Cigarette Smoking and Smoking Cessation, run by Duke 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 11 inclusion and 5 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 19 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. 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 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.
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?
Change in motivation to quit smoking, as measured by the Readiness to Change Questionnaire (time frame: Baseline to 9 weeks). The study lists 9 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 19 Oct 2020.