Smoking CessationNCT00606892
Varenicline and Nicotine Interactions in Humans (VA)
A study testing Varenicline and IV Nic in people with Smoking Cessation, run by Yale University at 1 site in United States.
Trial summary
To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Varenicline and IV Nic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Nov 2009
- 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
- Healthy volunteers accepted
- 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
- Carbon Monoxide (Alveolar) 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 heart disease, renal or hepatic diseases
- other medical conditions that the physician investigator deems as contraindicated for the subject to be in the study
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- recent psychiatric diagnosis and treatment for Axis I disorders including
- major depression, bipolar affective disorder,
- schizophrenia and panic disorder within the past year
Show all 10Show fewer
- Current dependence on alcohol
- drugs or treatments for drug
- alcohol addiction within the past 5 years
- Allergy to varenicline
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Hospital
West Haven, Connecticut, 06516
About this study
Official title: Varenicline Attenuates Some of the Subjective and Physiological Effects of Intravenous Nicotine in Humans.
To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. We predict that varenicline treatment will modify subjective, physiological and cognitive responses to IV nicotine.
Read the detailed description
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will have two 4-day treatment periods, in which they will be randomized to varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers will have daily clinic visits and receive their study medication. On Day 4, subjects will come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine (0.1, 0.4, and 0.7 mg per 70kg). This procedure will allow accurate assessment of varenicline effects on the subjective, physiological and cognitive responses to nicotine. Following a washout period, subjects will be crossed over to the alternative treatment.
- Conditions
- Smoking Cessation
- Being tested
- Varenicline, Placebo, IV Nic
- Keywords
- therapeutic effects
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
Varenicline (1 mg per day) given for 4 days prior to laboratory session
PlaceboDrug
Also called Sugar Pill
Sugar Pill
IV NicDrug
Also called IV Nicotine
IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo.
| Study group | Role | What they receive |
|---|---|---|
| Placebo First, varenicline, + IV Nic | Experimental | Subjects received a Placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg).After a minimum of a 5 day washout subjects then received varenicline tablet (1mg). once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,0.7 mg per 70kg). Receives: Drug: Varenicline; Drug: Placebo; Drug: IV Nic |
| Varenicline first, placebo, + IV Nic | Experimental | Subjects received Varenicline tablet (1 mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg). After a washout of a minimum of 5 days subjects then received placebo tablet for per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,, and 0.7mg per 70 kg). Receives: Drug: Varenicline; Drug: Placebo; Drug: IV Nic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Responses to Intravenous Nicotine
The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from "not at all" (a score of 0) to "extremely" with a maximum score of 100.
Measured: 30 minutes after each nicotine infusion
Secondary outcomes (4)
Mean Reaction Time (RT) on Modified Stroop Task.
A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues).
Measured: pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)
Cotinine Levels
Subject Cotinine Levels before each laboratory session.
Measured: Before each laboratory session on day 5
Heart Rate
The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated.
Measured: 30 minutes after each nicotine infusion
Changes in Systolic and Diastolic Blood Pressure
The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion.
Measured: 30 minutes after each nicotine infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionNov 2008
- Study completionNov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Mehmet Sofuoglu, M.D., Ph.D., Principal investigator, Yale University Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606892
- Sponsor's protocol ID
- HIC # 0702002338
- Other IDs
- MIRECC 000000000, DPMC, R01DA014537
- Status last verified
- Sep 2014
- First submitted
- 23 Jan 2008
- Last updated
- 25 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sofuoglu M, Herman AI, Mooney M, Waters AJ. Varenicline attenuates some of the subjective and physiological effects of intravenous nicotine in humans. Psychopharmacology (Berl). 2009 Nov;207(1):153-62. doi: 10.1007/s00213-009-1643-z. Epub 2009 Aug 20.
PubMed 19693492
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline Attenuates Some of the Subjective and Physiological Effects of Intravenous Nicotine in Humans.
- ClinicalTrials.gov ID
- NCT00606892
- Acronym / sponsor ID
- HIC # 0702002338
- Conditions
- Smoking Cessation
- Keywords
- therapeutic effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs, National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. We predict that varenicline treatment will modify subjective, physiological and cognitive responses to IV nicotine.
Detailed description
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will have two 4-day treatment periods, in which they will be randomized to varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers will have daily clinic visits and receive their study medication. On Day 4, subjects will come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine (0.1, 0.4, and 0.7 mg per 70kg). This procedure will allow accurate assessment of varenicline effects on the subjective, physiological and cognitive responses to nicotine. Following a washout period, subjects will be crossed over to the alternative treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo First, varenicline, + IV Nic | Experimental | Drug: Varenicline, Drug: Placebo, Drug: IV NicSubjects received a Placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg).After a minimum of a 5 day washout subjects then received varenicline tablet (1mg). once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,0.7 mg per 70kg). |
| Varenicline first, placebo, + IV Nic | Experimental | Drug: Varenicline, Drug: Placebo, Drug: IV NicSubjects received Varenicline tablet (1 mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg). After a washout of a minimum of 5 days subjects then received placebo tablet for per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,, and 0.7mg per 70 kg). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- 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
- Carbon Monoxide (Alveolar) level > 10ppm
- For women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods
Key exclusion criteria (10 listed)
- History of heart disease, renal or hepatic diseases
- other medical conditions that the physician investigator deems as contraindicated for the subject to be in the study
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- recent psychiatric diagnosis and treatment for Axis I disorders including
- major depression, bipolar affective 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 |
|---|---|---|
| VareniclineAlso: ChantixVarenicline (1 mg per day) given for 4 days prior to laboratory session | Drug | Placebo First, varenicline, + IV Nic, Varenicline first, placebo, + IV Nic |
| PlaceboAlso: Sugar PillSugar Pill | Drug | Placebo First, varenicline, + IV Nic, Varenicline first, placebo, + IV Nic |
| IV NicAlso: IV NicotineIV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo. | Drug | Placebo First, varenicline, + IV Nic, Varenicline first, placebo, + IV Nic |
Primary outcome
Subjective Responses to Intravenous Nicotine
Time frame: 30 minutes after each nicotine infusion
The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from "not at all" (a score of 0) to "extremely" with a maximum score of 100.
4 secondary outcomes
Mean Reaction Time (RT) on Modified Stroop Task.
Time frame: pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)
Cotinine Levels
Time frame: Before each laboratory session on day 5
Heart Rate
Time frame: 30 minutes after each nicotine infusion
Changes in Systolic and Diastolic Blood Pressure
Time frame: 30 minutes after each nicotine infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19693492Sofuoglu M, Herman AI, Mooney M, Waters AJ. Varenicline attenuates some of the subjective and physiological effects of intravenous nicotine in humans. Psychopharmacology (Berl). 2009 Nov;207(1):153-62. doi: 10.1007/s00213-009-1643-z. Epub 2009 Aug 20.
Related trials for Smoking Cessation
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
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
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 Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varenicline and IV Nic in people with Smoking Cessation, 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 10 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 25 Sep 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2014). 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?
Subjective Responses to Intravenous Nicotine (time frame: 30 minutes after each nicotine infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00606892, which also lists 1 linked publication.
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 25 Sep 2014.