Nicotine DependencePhase 2NCT00731055
Effects of Varenicline on Cigarette Self Administration
A Phase 2 study testing Varenicline in people with Nicotine Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The investigators hypothesize that varenicline will dose dependently attenuate the subjective effects of cigarettes after a period of abstinence. Also, treatment with varenicline will dose dependently weaken the severity of nicotine withdrawal symptoms. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2009
- Phase
- Phase 2
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A diagnosis of nicotine dependence with physiological dependence, smoking at least 15 cigarettes/day during the last 3 months.
- Not interested in treatment
- Medically healthy on the basis of physical examination and medical history, vital signs, EKG and laboratory tests, with a negative pregnancy test for females.
- Able to perform study procedures
- Males or females between the ages of 21-45 yrs
- Female participants agree to use an effective method of birth control during the course of the study
Who cannot join
- A diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications (within last 3 months)
- Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
- Currently seeking treatment for nicotine dependence
- Participants on parole or probation
- History of significant recent violent behavior
- Blood pressure > 150/90
- History of allergic reaction to any of the study medications
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
The investigators hypothesize that varenicline will dose dependently attenuate the subjective effects of cigarettes after a period of abstinence. Also, treatment with varenicline will dose dependently weaken the severity of nicotine withdrawal symptoms. Thirdly, we hypothesize that treatment with varenicline will dose dependently decrease cigarette self-administration in the model proposed.
Read the detailed description
Tobacco use is the leading preventable cause of death in the U.S.A. Every year 400,000 people die from cigarette smoking and in 2006, one out of every five deaths in the US were smoking related. Recent advances in laboratory studies of tobacco effects in humans and in understanding the effects of nicotine on the brain and behavior present an opportunity to advance medication development.
The addictive properties of nicotine are thought to be a result of nicotine triggering the acute release of dopamine, a pleasurable event that a person seeks to repeat. Varenicline is a partial agonist of the nicotine receptors, therefore also triggering the release of dopamine but in a more sustained and moderate manner, which could counter the low dopamine levels arising from a lack of nicotine and therefore aid craving. Also, by binding to these nicotine receptors in advance of smoking, it could stop nicotine from binding and creating pleasurable effects.
This study will assess the effect of acute treatment with varenicline and placebo on early tobacco withdrawal, acute effects of cigarettes and cigarette self-administration in cigarette-smoking volunteers. After overnight abstinence, participants will come into the lab and receive acute treatment with varying doses of varenicline or placebo and perform computer tests and fill out questionnaires. Then they will be given the opportunity to smoke under operational conditions (cigarette versus money choice). This study will employ a within-group, double-blind, randomized and counterbalanced design.
The main goal of this project is to improve the current laboratory model of smoking cessation and study the mechanism involved in smoking maintenance. We hypothesize that varenicline will dose-dependently: 1) decrease nicotine withdrawal symptoms, 2) decrease acute effects of cigarettes and 3) decrease self-administration of cigarettes in the laboratory paradigm. Showing the effectiveness of varenicline in the proposed laboratory model will confirm the model's predictive validity to detect clinically effective medication.
- Conditions
- Nicotine Dependence
- Being tested
- Varenicline, Placebo
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
4 doses of Varenicline. 1 capsule of either dose (0mg, 0.5mg, 1mg, 2 mg) in the morning on days at least 5 days apart.
PlaceboDrug
1 dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | Each participant participates in 4 consecutive interventions in random order.
1. Placebo, 1 capsule before the session
2. 0.5 mg varenicline, 1 capsule before the session 3.1 mg varenicline, 1 capsule before the session
4. 2 mg varenicline, 1 capsule before the session Receives: Drug: Varenicline; Drug: Placebo |
| Intervention 2 | Experimental | Each participant participates in 4 consecutive interventions in random order. 1.0.5 mg varenicline, 1 capsule before the session 2. 1 mg varenicline, 1 capsule before the session 3.2 mg varenicline, 1 capsule before the session 4. Placebo, 1 capsule before the session Receives: Drug: Varenicline; Drug: Placebo |
| Intervention 3 | Experimental | Each participant participates in 4 consecutive interventions in random order. 1.1 mg varenicline, 1 capsule before the session 2. 2 mg varenicline, 1 capsule before the session 3.Placebo, 1 capsule before the session 4. 0.5 mg varenicline, 1 capsule before the session Receives: Drug: Varenicline; Drug: Placebo |
| Intervention 4 | Experimental | Each participant participates in 4 consecutive interventions in random order. 1.2 mg varenicline, 1 capsule before the session 2. Placebo, 1 capsule before the session 3. 0.5 mg varenicline, 1 capsule before the session 4. 1 mg varenicline, 1 capsule before the session Receives: Drug: Varenicline; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette Choice
Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.
Measured: During each of the four weekly 6-hour experimental sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionMay 2009
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Adam Bisaga, New York State Psychiatric Institute
- Investigators
- Adam Bisaga, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731055
- Sponsor's protocol ID
- #5649/NIDA-17572-4
- Other IDs
- R01DA017572, DPMCDA
- Status last verified
- May 2018
- First submitted
- 6 Aug 2008
- Last updated
- 18 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Varenicline on Cigarette Self Administration
- ClinicalTrials.gov ID
- NCT00731055
- Acronym / sponsor ID
- #5649/NIDA-17572-4
- Conditions
- Nicotine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 1 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that varenicline will dose dependently attenuate the subjective effects of cigarettes after a period of abstinence. Also, treatment with varenicline will dose dependently weaken the severity of nicotine withdrawal symptoms. Thirdly, we hypothesize that treatment with varenicline will dose dependently decrease cigarette self-administration in the model proposed.
Detailed description
Tobacco use is the leading preventable cause of death in the U.S.A. Every year 400,000 people die from cigarette smoking and in 2006, one out of every five deaths in the US were smoking related. Recent advances in laboratory studies of tobacco effects in humans and in understanding the effects of nicotine on the brain and behavior present an opportunity to advance medication development.
The addictive properties of nicotine are thought to be a result of nicotine triggering the acute release of dopamine, a pleasurable event that a person seeks to repeat. Varenicline is a partial agonist of the nicotine receptors, therefore also triggering the release of dopamine but in a more sustained and moderate manner, which could counter the low dopamine levels arising from a lack of nicotine and therefore aid craving. Also, by binding to these nicotine receptors in advance of smoking, it could stop nicotine from binding and creating pleasurable effects.
This study will assess the effect of acute treatment with varenicline and placebo on early tobacco withdrawal, acute effects of cigarettes and cigarette self-administration in cigarette-smoking volunteers. After overnight abstinence, participants will come into the lab and receive acute treatment with varying doses of varenicline or placebo and perform computer tests and fill out questionnaires. Then they will be given the opportunity to smoke under operational conditions (cigarette versus money choice). This study will employ a within-group, double-blind, randomized and counterbalanced design.
The main goal of this project is to improve the current laboratory model of smoking cessation and study the mechanism involved in smoking maintenance. We hypothesize that varenicline will dose-dependently: 1) decrease nicotine withdrawal symptoms, 2) decrease acute effects of cigarettes and 3) decrease self-administration of cigarettes in the laboratory paradigm. Showing the effectiveness of varenicline in the proposed laboratory model will confirm the model's predictive validity to detect clinically effective medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Drug: Varenicline, Drug: PlaceboEach participant participates in 4 consecutive interventions in random order. 1. Placebo, 1 capsule before the session 2. 0.5 mg varenicline, 1 capsule before the session 3.1 mg varenicline, 1 capsule before the session 4. 2 mg varenicline, 1 capsule before the session |
| Intervention 2 | Experimental | Drug: Varenicline, Drug: PlaceboEach participant participates in 4 consecutive interventions in random order. 1.0.5 mg varenicline, 1 capsule before the session 2. 1 mg varenicline, 1 capsule before the session 3.2 mg varenicline, 1 capsule before the session 4. Placebo, 1 capsule before the session |
| Intervention 3 | Experimental | Drug: Varenicline, Drug: PlaceboEach participant participates in 4 consecutive interventions in random order. 1.1 mg varenicline, 1 capsule before the session 2. 2 mg varenicline, 1 capsule before the session 3.Placebo, 1 capsule before the session 4. 0.5 mg varenicline, 1 capsule before the session |
| Intervention 4 | Experimental | Drug: Varenicline, Drug: PlaceboEach participant participates in 4 consecutive interventions in random order. 1.2 mg varenicline, 1 capsule before the session 2. Placebo, 1 capsule before the session 3. 0.5 mg varenicline, 1 capsule before the session 4. 1 mg varenicline, 1 capsule before the session |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A diagnosis of nicotine dependence with physiological dependence, smoking at least 15 cigarettes/day during the last 3 months.
- Not interested in treatment
- Medically healthy on the basis of physical examination and medical history, vital signs, EKG and laboratory tests, with a negative pregnancy test for females.
- Able to perform study procedures
- Males or females between the ages of 21-45 yrs
Key exclusion criteria (8 listed)
- A diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications (within last 3 months)
- Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
- Currently seeking treatment for nicotine dependence
- Participants on parole or probation
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 |
|---|---|---|
| VareniclineAlso: Chantix4 doses of Varenicline. 1 capsule of either dose (0mg, 0.5mg, 1mg, 2 mg) in the morning on days at least 5 days apart. | Drug | Intervention 1, Intervention 2, Intervention 3, Intervention 4 |
| Placebo1 dose of placebo | Drug | Intervention 1, Intervention 2, Intervention 3, Intervention 4 |
Primary outcome
Cigarette Choice
Time frame: During each of the four weekly 6-hour experimental sessions
Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Adam Bisaga, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Varenicline in people with Nicotine Dependence, run by New York State Psychiatric Institute 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 6 inclusion and 8 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 18 Jun 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2015). 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?
Cigarette Choice (time frame: During each of the four weekly 6-hour experimental sessions). 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 18 Jun 2018.