Nicotine DependenceADHDenicNCT02599571
Effects of Nicotine Reduction on Smoking Behavior in ADHD Smokers
A study testing Very low nicotine content cigarettes and Conventional nicotine content cigarettes in people with Nicotine Dependence and ADHD, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to investigate the impact of different nicotine levels in cigarettes with individuals who have ADHD. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, ADHD
- What is being tested?
- Very low nicotine content cigarettes and Conventional nicotine content cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Mar 2016to 12 Sep 2019
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 40
- Smoke an average of 5-40 cigarettes per day for at least 1 year
- Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 6)
- Primary diagnosis of ADHD, any subtype as assessed by the CAADID; T-Score > 65 on one of the DSM- V relevant scales (Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index) on the Self-Report version of the CAARS; Clinician Rated ADHD-RS score >24.
- Cognitive functioning > 80 as assessed by the KBIT-II
Who cannot join
- Intention to quit smoking in the next 30 days
- Currently seeking treatment for smoking cessation
- Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
- A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
- Using other tobacco products more than 9 days in the past 30 days
- Significant unstable medical conditions (any significant change in a serious medical condition occurring during the past 3 months including cardiovascular disease, COPD, and cancer, as determined by the study physician at each site)
Show all 23Show fewer
- Significant unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the study physician at each site)
- Any Axis I Psychiatric Disorder as assessed by the MINI that is significantly impairing and/or would contraindicate participation in the study
- Psychiatric medication changes in the past 3 months including new prescriptions, changes in dosages or discontinuation of medications
- Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP (Marijuana will be tested for but will not be an exclusionary criterion, participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded, participants failing the toxicology screen will be allowed to re-screen once. These participants will need to be re-consented before being rescreened to ensure they have received adequate informed consent.)
- Breath alcohol level > 0.01 (Participants failing the breath alcohol screen will be allowed to re-screen once. These participants will need to be re-consented before being rescreened to ensure they have received adequate informed consent.)
- Current diagnosis of DSM alcohol or drug use disorder (except for nicotine)
- Pregnant, trying to become pregnant or breastfeeding
- Smoking 'roll your own cigarettes' exclusively
- Currently taking anticonvulsant medications including: Phenytoin [Brand Name: Dilantin], Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol], Oxcarbazepine [Brand Name: Trileptal], Primidone [Brand Name: Mysoline], Phenobarbital
- CO reading >80 ppm
- Systolic BP between 90 and 160 (If below 90 then asymptomatic. Participants failing for blood pressure will be allowed to re-screen once.)
- Diastolic BP between 50 and 100 (If below 50 then asymptomatic. Participants failing for blood pressure will be allowed to re-screen once.)
- Heart rate between 45 and 115 bpm (If below 45 then asymptomatic. Participants failing for heart rate will be allowed to re-screen once.)
- Indicating any suicidal ideation in the past month or suicide attempts in the past 10 years.
- Inability to independently read and comprehend the consent form and other written study materials and measures.
- Having participated in a research study during the past three months in which the participant: Smoked a cigarette that was not his/her usual brand cigarette for more than one day, used any tobacco products beyond normal use for more than one day, used any nicotine replacement products or smoking cessation medications for more than one day
- Any previous experience using SPECTRUM cigarettes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27705
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to investigate the impact of different nicotine levels in cigarettes with individuals who have ADHD.
Read the detailed description
The purpose of this study is to examine the effects of very low nicotine content (VLNC) cigarettes on smoking behavior, psychiatric symptoms and functioning, and acceptability and adverse outcomes in young adult smokers with ADHD. Participants will attend a screening session, 2 baseline sessions, 6 experimental sessions, and a 30 day follow-up visit. Participants will be asked to smoke only the study cigarettes that we provide for 6 weeks.
- Conditions
- Nicotine Dependence, ADHD
- Being tested
- Very low nicotine content cigarettes, Conventional nicotine content cigarettes
- Medical subject headings
- Tobacco Use Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low nicotine content cigarettesOther
Also called Tobacco, Cigarettes
Cigarettes containing a reduced amount of nicotine
Conventional nicotine content cigarettesOther
Also called Tobacco, Cigarettes
Cigarettes containing a normal amount of nicotine
| Study group | Role | What they receive |
|---|---|---|
| Very low nicotine content cigarettes | Other | Reduced nicotine content cigarettes. Receives: Other: Very low nicotine content cigarettes; Other: Conventional nicotine content cigarettes |
| Conventional nicotine content cigarettes | Other | Conventional nicotine content cigarettes. Receives: Other: Very low nicotine content cigarettes; Other: Conventional nicotine content cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cigarettes smoked per day
Self-reported number of cigarettes smoked per day
Measured: Six weeks
Composite measure of influence of reduced nicotine content on ADHD symptoms measured by ADHD Rating Scale and Clinical Global Impressions Scale along with related measures of cognition measured by the N-Back Task and the Continuous Performance Test
Composite of ADHD symptom questionnaires, inhibitory control, working memory
Measured: Six weeks
Composite measure of outcomes associated with acceptability; withdrawal measured by the MNWS and compliance measured by Time-Line Follow-Back questionnaire and daily self-report cigarette use
Composite of study dropout, compliance, changes in physical health
Measured: Six weeks
Secondary outcomes (2)
Measures of discomfort/dysfunction; withdrawal and depression
Withdrawal scale and depression measures
Measured: Six weeks
Measures of other health-related behaviors; dependence measures
Drug and alcohol use questionnaires
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start30 Mar 2016
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Why it stopped: sponsor discontinued funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Food and Drug Administration (FDA), University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Scott Kollins, Ph.D., Principal investigator, Duke ADHD Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599571
- Sponsor's protocol ID
- Pro00066144
- Other IDs
- 1R01HD083404
- Acronym
- ADHDenic
- Status last verified
- Jan 2020
- First submitted
- 2 Nov 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotine Reduction on Smoking Behavior in ADHD Smokers
- ClinicalTrials.gov ID
- NCT02599571
- Acronym / sponsor ID
- ADHDenic / Pro00066144
- Conditions
- Nicotine Dependence, ADHD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor discontinued funding
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Food and Drug Administration (FDA), University of Pittsburgh
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 6 Nov 2015 (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 investigate the impact of different nicotine levels in cigarettes with individuals who have ADHD.
Detailed description
The purpose of this study is to examine the effects of very low nicotine content (VLNC) cigarettes on smoking behavior, psychiatric symptoms and functioning, and acceptability and adverse outcomes in young adult smokers with ADHD. Participants will attend a screening session, 2 baseline sessions, 6 experimental sessions, and a 30 day follow-up visit. Participants will be asked to smoke only the study cigarettes that we provide for 6 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very low nicotine content cigarettes | Other | Other: Very low nicotine content cigarettes, Other: Conventional nicotine content cigarettesReduced nicotine content cigarettes. |
| Conventional nicotine content cigarettes | Other | Other: Very low nicotine content cigarettes, Other: Conventional nicotine content cigarettesConventional nicotine content cigarettes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 - 40
- Smoke an average of 5-40 cigarettes per day for at least 1 year
- Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 6)
- Primary diagnosis of ADHD, any subtype as assessed by the CAADID; T-Score > 65 on one of the DSM- V relevant scales (Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index) on the Self-Report version of the CAARS; Clinician Rated ADHD-RS score >24.
- Cognitive functioning > 80 as assessed by the KBIT-II
Key exclusion criteria (23 listed)
- Intention to quit smoking in the next 30 days
- Currently seeking treatment for smoking cessation
- Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
- A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
- Using other tobacco products more than 9 days in the past 30 days
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 |
|---|---|---|
| Very low nicotine content cigarettesAlso: Tobacco, CigarettesCigarettes containing a reduced amount of nicotine | Other | Conventional nicotine content cigarettes, Very low nicotine content cigarettes |
| Conventional nicotine content cigarettesAlso: Tobacco, CigarettesCigarettes containing a normal amount of nicotine | Other | Conventional nicotine content cigarettes, Very low nicotine content cigarettes |
Primary outcome
Number of cigarettes smoked per day
Time frame: Six weeks
Self-reported number of cigarettes smoked per day
Composite measure of influence of reduced nicotine content on ADHD symptoms measured by ADHD Rating Scale and Clinical Global Impressions Scale along with related measures of cognition measured by the N-Back Task and the Continuous Performance Test
Time frame: Six weeks
Composite of ADHD symptom questionnaires, inhibitory control, working memory
Composite measure of outcomes associated with acceptability; withdrawal measured by the MNWS and compliance measured by Time-Line Follow-Back questionnaire and daily self-report cigarette use
Time frame: Six weeks
Composite of study dropout, compliance, changes in physical health
2 secondary outcomes
Measures of discomfort/dysfunction; withdrawal and depression
Time frame: Six weeks
Measures of other health-related behaviors; dependence measures
Time frame: Six weeks
Results and safety
The study was stopped early (reason given: sponsor discontinued funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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 Kollins, Ph.D. principal investigator
Duke ADHD Program
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low nicotine content cigarettes and Conventional nicotine content cigarettes in people with Nicotine Dependence and ADHD, run by Duke University at 2 sites 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 5 inclusion and 23 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study was stopped early (reason given: sponsor discontinued funding). Results are not available in the source record.
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 per day (time frame: Six weeks). The study lists 3 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 27 Jan 2020.