Nicotine DependenceNCT01880099
A Study to Help People Quit Smoking.
A study testing Galantamine 8mg and Galantamine 16mg in people with Nicotine Dependence, run by Yale University at 1 site in United States.
Trial summary
You are invited to participate in a research study at the VA Connecticut Healthcare System (West Haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Galantamine 8mg and Galantamine 16mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 cigarettes daily;
- in good health as verified by medical history, screening examination, and screening laboratory tests;
- for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Who cannot join
- History of GAL allergy;
- requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (in the past 6 months);
- serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, or hepatic disorders;
- abuse of alcohol or any other illicit or prescription drugs;
- use of any other tobacco products, including smokeless tobacco and nicotine products; and
- inability to fulfill all scheduled visits and examination procedures throughout the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cholinergic Enhancement as a Treatment for Nicotine Addiction
You are invited to participate in a research study at the VA Connecticut Healthcare System (West Haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. You have been invited to participate because you currently smoke cigarettes, and want to quit smoking. If you are eligible and agree to be in the study, your participation will last for approximately 8 weeks. To determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking self-administration in a human laboratory model and b) improving abstinence rates at the end of 4 weeks of treatment.
Read the detailed description
We propose a double-blind, placebo-controlled, outpatient study with a between-groups design. Seventy-two male and female smokers will be randomly assigned to one of the 3 treatment conditions: GAL (8 or 16 mg/day) or placebo. The dose of GAL will be gradually increased to the target doses over a 2-week period (Table 2). During Week 3, following overnight abstinence from smoking, participants will present for a laboratory Test Session in which they will have the option of cigarette self-administration. After this Test Session is completed, smokers will be maintained on their randomized medication condition for an additional 4-week period. Smokers will establish a quit date at the beginning of this Treatment Phase, and will receive brief weekly behavioral treatment for the 4 weeks of this phase. Additionally, at the beginning of Week 3, participants will be given a PDA that will administer EMA assessments. The study medication will be tapered after the end of Week 4 of the Treatment Phase. Participants will be contacted by phone at one week, and one month, after treatment termination to inquire about any adverse events and about their recent smoking status.
- Conditions
- Nicotine Dependence
- Being tested
- placebo, Galantamine 8mg, Galantamine 16mg
- Keywords
- addiction, smoking, tobacco, cigarettes
- Medical subject headings
- Tobacco Use Disorder, Behavior, Addictive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called sugar pill
placebo compared to 8mg of Galantamine
Galantamine 8mgDrug
Also called Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl
8mg of galantamine compared to placebo
Galantamine 16mgDrug
Also called Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl
16mg of galantamine compared to placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo (sugar Pill) will be given daily for 7 weeks. Receives: Drug: placebo |
| galantamine 8mg | Active comparator | Galantamine extended release (8mg) will be given daily for 7 weeks. Receives: Drug: Galantamine 8mg |
| Galantamine 16mg | Active comparator | Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine. Receives: Drug: Galantamine 16mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Choice Procedure
After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.
Measured: Data was acquired during a single test session during week 3 of drug intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Mehmet Sofuoglu, M.D.,Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880099
- Sponsor's protocol ID
- 1306012154
- Other IDs
- 1R21DA034815-01A1
- Status last verified
- Mar 2020
- First submitted
- 13 Jun 2013
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholinergic Enhancement as a Treatment for Nicotine Addiction
- ClinicalTrials.gov ID
- NCT01880099
- Acronym / sponsor ID
- 1306012154
- Conditions
- Nicotine Dependence
- Keywords
- addiction, smoking, tobacco, cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Posted 25 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
You are invited to participate in a research study at the VA Connecticut Healthcare System (West Haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. You have been invited to participate because you currently smoke cigarettes, and want to quit smoking. If you are eligible and agree to be in the study, your participation will last for approximately 8 weeks. To determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking self-administration in a human laboratory model and b) improving abstinence rates at the end of 4 weeks of treatment.
Detailed description
We propose a double-blind, placebo-controlled, outpatient study with a between-groups design. Seventy-two male and female smokers will be randomly assigned to one of the 3 treatment conditions: GAL (8 or 16 mg/day) or placebo. The dose of GAL will be gradually increased to the target doses over a 2-week period (Table 2). During Week 3, following overnight abstinence from smoking, participants will present for a laboratory Test Session in which they will have the option of cigarette self-administration. After this Test Session is completed, smokers will be maintained on their randomized medication condition for an additional 4-week period. Smokers will establish a quit date at the beginning of this Treatment Phase, and will receive brief weekly behavioral treatment for the 4 weeks of this phase. Additionally, at the beginning of Week 3, participants will be given a PDA that will administer EMA assessments. The study medication will be tapered after the end of Week 4 of the Treatment Phase. Participants will be contacted by phone at one week, and one month, after treatment termination to inquire about any adverse events and about their recent smoking status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboPlacebo (sugar Pill) will be given daily for 7 weeks. |
| galantamine 8mg | Active comparator | Drug: Galantamine 8mgGalantamine extended release (8mg) will be given daily for 7 weeks. |
| Galantamine 16mg | Active comparator | Drug: Galantamine 16mgGalantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine. |
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 10 cigarettes daily;
- in good health as verified by medical history, screening examination, and screening laboratory tests;
- for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Key exclusion criteria (6 listed)
- History of GAL allergy;
- requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (in the past 6 months);
- serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, or hepatic disorders;
- abuse of alcohol or any other illicit or prescription drugs;
- use of any other tobacco products, including smokeless tobacco and nicotine products; and
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 |
|---|---|---|
| placeboAlso: sugar pillplacebo compared to 8mg of Galantamine | Drug | placebo |
| Galantamine 8mgAlso: Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl8mg of galantamine compared to placebo | Drug | galantamine 8mg |
| Galantamine 16mgAlso: Acetylcholinesterase inhibitors, Galantamine ER,, Razadyne, Razadyne ER, Reminyl16mg of galantamine compared to placebo | Drug | Galantamine 16mg |
Primary outcome
Smoking Choice Procedure
Time frame: Data was acquired during a single test session during week 3 of drug intervention.
After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
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 study testing Galantamine 8mg and Galantamine 16mg in people with Nicotine Dependence, 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 6 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 23 Mar 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Smoking Choice Procedure (time frame: Data was acquired during a single test session during week 3 of drug intervention.). 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 23 Mar 2020.