SmokingPhase 1NCT01417429
Galantamine Effects on Nicotine Responses in Smokers
A Phase 1 study testing Galantamine and IV Nicotine in people with Smoking and Tobacco Withdrawal, run by Yale University at 1 site in United States.
Trial summary
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will first have two 4-day treatment periods, in which they will be randomized to galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day washout period. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Smoking, Tobacco Withdrawal
- What is being tested?
- Galantamine and IV Nicotine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2011
- 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
- No healthy volunteers
- Adult
Who may be able to join
- female and male smokers, aged 18 to 55 years;
- history of smoking daily for the past 12 months, at least 15 cigarettes daily;
- CO level > 10ppm;
- for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Who cannot join
- history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
- regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and/or recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year;
- current dependence on alcohol or on drugs or treatments for drug or alcohol addiction ;
- use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and AV block, or NSAIDs, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding;
- known allergy to galantamine
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Veterans Affairs
West Haven, Connecticut, 06516
About this study
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will first have two 4-day treatment periods, in which they will be randomized to galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day washout period. During the first 3-days of each treatment period, smokers will have daily clinic visits, where they will receive study medications and any adverse effects from study medications will be monitored. Starting at 10 p.m. on Day 1 of each treatment period, subjects will refrain from smoking for approximately 2.5 days, until the experimental session on Day 4. Compliance with non-smoking will be verified by CO levels < 10 ppm. During the experimental sessions, subjects will receive saline or 1.0 mg/70 kg of nicotine intravenously in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced among subjects such that equal number of subjects will receive saline first or nicotine first. Following each saline and nicotine treatments, physiological, subjective and cognitive measurements will be obtained
Read the detailed description
In this double-blind, crossover study, the investigators are proposing to evaluate galantamine's effects on the subjective nicotine effects and the severity of tobacco withdrawal symptoms. Twenty four male and female smokers will first have two 4-day treatment periods, in which subjects will be randomized to galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day washout period. This range of washout period, while minimizing carryover medication effects between treatments, will provide flexibility for subjects to comply with study procedures. During study participation, subjects will be instructed to continue to smoke as usual during the study except the 2.5 days of smoking abstinence before each test session. Starting at 10 p.m. on Day 1 of each treatment period, subjects will refrain from smoking for approximately 2.5 days, until the test session on Day 4. Subjects will have twice daily outpatient visits during the first 3 days and a test session on day 4. During the outpatient visits, study medication will be administered and tobacco withdrawal symptoms and compliance with smoking abstinence will be monitored. On Day 4 of each treatment phase subjects will have a test session, where they will receive saline or 1.0 mg/70 kg of nicotine intravenously in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced among subjects such that equal number of subjects will receive saline first or nicotine first. Following each saline and nicotine administration, physiological, subjective and cognitive measurements will be obtained.
Currently 12 subjects completed this protocol. This study is in data analysis. (April 2011)
- Conditions
- Smoking, Tobacco Withdrawal
- Being tested
- Galantamine, IV Nicotine
- Keywords
- galantamine, subjective nicotine, tobacco withdrawal symptoms, nicotine
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalantamineDrug
Also called Razadyne, Razadyne ER
8mg/a day or placebo
IV NicotineDrug
Also called liquid nicotine
1.0 mg/70 kg of nicotine against saline
| Study group | Role | What they receive |
|---|---|---|
| Galantamine | Active comparator | galantamine will be given with intravenous nicotine Receives: Drug: Galantamine |
| Nicotine | Experimental | Subject will be given IV Nicotine Receives: Drug: IV Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galantamine Effects on Nicotine Responses in Smokers
Urine sample and blood samples anticipated for 24 male and females
Measured: 1 year to complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Yale 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mehmet Sofuoglu, Yale University
- Investigators
- Mehmet Sofuoglu, M.D., Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417429
- Sponsor's protocol ID
- HIC1001006227
- Other IDs
- NCT01417429
- Status last verified
- Jul 2015
- First submitted
- 5 Apr 2011
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galantamine Effects on Nicotine Responses in Smokers
- ClinicalTrials.gov ID
- NCT01417429
- Acronym / sponsor ID
- HIC1001006227
- Conditions
- Smoking, Tobacco Withdrawal
- Keywords
- galantamine, subjective nicotine, tobacco withdrawal symptoms, nicotine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Aug 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.
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will first have two 4-day treatment periods, in which they will be randomized to galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day washout period. During the first 3-days of each treatment period, smokers will have daily clinic visits, where they will receive study medications and any adverse effects from study medications will be monitored. Starting at 10 p.m. on Day 1 of each treatment period, subjects will refrain from smoking for approximately 2.5 days, until the experimental session on Day 4. Compliance with non-smoking will be verified by CO levels < 10 ppm. During the experimental sessions, subjects will receive saline or 1.0 mg/70 kg of nicotine intravenously in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced among subjects such that equal number of subjects will receive saline first or nicotine first. Following each saline and nicotine treatments, physiological, subjective and cognitive measurements will be obtained
Detailed description
In this double-blind, crossover study, the investigators are proposing to evaluate galantamine's effects on the subjective nicotine effects and the severity of tobacco withdrawal symptoms. Twenty four male and female smokers will first have two 4-day treatment periods, in which subjects will be randomized to galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day washout period. This range of washout period, while minimizing carryover medication effects between treatments, will provide flexibility for subjects to comply with study procedures. During study participation, subjects will be instructed to continue to smoke as usual during the study except the 2.5 days of smoking abstinence before each test session. Starting at 10 p.m. on Day 1 of each treatment period, subjects will refrain from smoking for approximately 2.5 days, until the test session on Day 4. Subjects will have twice daily outpatient visits during the first 3 days and a test session on day 4. During the outpatient visits, study medication will be administered and tobacco withdrawal symptoms and compliance with smoking abstinence will be monitored. On Day 4 of each treatment phase subjects will have a test session, where they will receive saline or 1.0 mg/70 kg of nicotine intravenously in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced among subjects such that equal number of subjects will receive saline first or nicotine first. Following each saline and nicotine administration, physiological, subjective and cognitive measurements will be obtained.
Currently 12 subjects completed this protocol. This study is in data analysis. (April 2011)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galantamine | Active comparator | Drug: Galantaminegalantamine will be given with intravenous nicotine |
| Nicotine | Experimental | Drug: IV NicotineSubject will be given IV Nicotine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female and male smokers, aged 18 to 55 years;
- history of smoking daily for the past 12 months, at least 15 cigarettes daily;
- CO level > 10ppm;
- for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Key exclusion criteria (5 listed)
- history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
- regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and/or recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year;
- current dependence on alcohol or on drugs or treatments for drug or alcohol addiction ;
- use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and AV block, or NSAIDs, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding;
- known allergy to galantamine
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 |
|---|---|---|
| GalantamineAlso: Razadyne, Razadyne ER8mg/a day or placebo | Drug | Galantamine |
| IV NicotineAlso: liquid nicotine1.0 mg/70 kg of nicotine against saline | Drug | Nicotine |
Primary outcome
Galantamine Effects on Nicotine Responses in Smokers
Time frame: 1 year to complete
Urine sample and blood samples anticipated for 24 male and females
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 8 Jul 2015.
Related trials for 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 recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
Mehmet Sofuoglu, M.D., Ph.D. principal investigator
Yale University
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 Galantamine and IV Nicotine in people with Smoking and Tobacco Withdrawal, run by Yale 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 4 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 8 Jul 2015. 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?
Galantamine Effects on Nicotine Responses in Smokers (time frame: 1 year to complete). 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 Jul 2015.