Tobacco DependenceNCT00873535
Effect of Varenicline on Reactivity to Smoking and Drinking Cues
A study testing Varenicline in people with Tobacco Dependence and Alcohol Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking. However, very little research has been conducted into the nature of this co-occurrence. Thus, the main aim of this study is to assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence, Alcohol 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
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Jan 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Treatment seeking smokers
- Age 18 to 65 years
- Smoke ≥ 10 cigarettes per day
- Fagerstrom Test of Nicotine Dependence score > 3
- Alcohol Use Disorders Identification Test (AUDIT) > 8
- Drink > 25 drinks per week for males or > 20 drinks per week for females
Show all 14Show fewer
- Able to provide written informed consent
- Treatment seeking smokers
- Age 18 to 65 years
- Smoke ≥ 10 cigarettes per day
- Fagerstrom Test of Nicotine Dependence score > 3
- Alcohol Use Disorders Identification Test(AUDIT) < 8
- Drink < 14 drinks per week for males or < 9 drinks per week for females
- Able to provide written informed consent
Who cannot join
- Any medical condition requiring immediate investigation or treatment
- Beck Depression Inventory score >16
- Insulin-dependent diabetes
- Drink > 70 standard alcoholic drinks per week for males or drink > 52 standard alcoholic drinks per week for females
- Pregnancy or lactation
- Current DSM-IV Axis 1 psychiatric disorder
Show all 14Show fewer
- Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco and alcohol.
- Any medical condition requiring immediate investigation or treatment
- Beck Depression Inventory score >16
- Insulin-dependent diabetes
- Drink > 14 standard alcoholic drinks per week for males or > 9 standard alcoholic drinks per week for females
- Pregnancy or lactation
- Current DSM-IV Axis 1 psychiatric disorder
- Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Varenicline on Reactivity to Smoking and Drinking Cues in Individuals With Concurrent Tobacco Dependence and Alcohol Use
Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking. However, very little research has been conducted into the nature of this co-occurrence. Thus, the main aim of this study is to assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking smokers after two weeks treatment of varenicline.
Hypotheses
- Two weeks of varenicline treatment will significantly decrease cue-induced tobacco craving compared to placebo (Due to the actions of varenicline on alpha-4-beta-2 receptors and its downstream effect on dopamine release).
- Varenicline will decrease cue-induced alcohol craving compared to placebo.
- The impact of Varenicline on cue-induced alcohol craving will be greater in heavy drinkers compared to social drinkers.
Read the detailed description
The relationship between alcohol and tobacco dependence needs to be addressed as such populations are generally excluded from clinical trials involving smoking cessation pharmacotherapy. Furthermore, the effect of Varenicline(Pfizer Pharmaceuticals)treatment on tobacco cue-induced craving has not been empirically measured, nor has the effect of varenicline on alcohol consumption. In addition to being an effective aid in smoking cessation, preliminary evidence has shown that Varenicline can decrease alcohol consumption in animal models.
Varenicline is a partial agonist of the α4β2 nicotinic acetylcholine receptor. This drug's partial agonist effect allows for the activation of this receptor at a lesser degree than nicotine while simultaneously preventing nicotine binding due to the drugs high affinity (i.e.: antagonist effect) for this receptor subtype.
Varenicline has recently been approved in Canada as an aid for smoking cessation. This study will be a double-blind, placebo-controlled randomized study. It will assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking smokers after two weeks of treatment with either varenicline or placebo.Ultimately This study may help to further understand the association between smoking and drinking alcohol.
This study will consist of two study groups composed of 40 subjects each being randomized to receive either placebo or varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). One group will be heavy smokers and heavy drinkers while the other will be heavy smokers and social drinkers. Upon entering the study, subjects will undergo baseline cognitive and craving measures for both tobacco and alcohol associated cue presentations prior to randomization to varenicline or placebo. Subjects will be provided a 1-week supply of study medications and directions for use. During this period, subjects will be requested to complete a diary outlining their cigarette and alcohol craving and consumption each day and outline any adverse effects. Upon completion of this 1-week period, subjects will attend the Centre for Addiction and Mental Health (CAMH) where their old pill bottles and daily diaries will be collected and they will be supplied with study medication (1mg varenicline taken twice daily or placebo) and daily diary for an additional week. At this visit, subjects will complete the symptom checklist. At the end of the second week of treatment, subjects will be requested to return to CAMH where craving for tobacco and alcohol and cue-reactivity will be assessed in a similar manner as to study day After study completion, all subjects will be given the option to continue with varenicline in a 12-week treatment plan through the Nicotine Dependence Clinic.
- Conditions
- Tobacco Dependence, Alcohol Dependence
- Being tested
- Varenicline, Placebo
- Keywords
- Nicotine, Nicotine dependence, Smoking cessation, Alcohol, Alcohol dependence, Alcohol cessation, Treatment, Smoking, Cigarette, Heavy drinkers, Social drinkers, Co-morbidity of alcohol and nicotine dependence, Nicotine receptor, Nicotinic receptor, Nicotinic acetycholine receptor, Alpha-4-beta-2 nicotinic acetycholine receptor, Cholinergic receptor, Dopamine, Craving, Diary
- Medical subject headings
- Tobacco Use Disorder, Alcoholism, Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix, Champix
This group (N=40) will receive Varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20).
PlaceboDrug
This group (n=40) will receive matching placebo capsules in the identical dosing regimen described for the Varenicline arm. The group will consist of heavy smokers who are heavy drinkers (n=20) and heavy smokers who are social drinkers (n=20).
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Active comparator | This group (N=40) will receive Varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20). Receives: Drug: Varenicline |
| Placebo | Placebo comparator | This group (N=40) will receive placebo in the same dosing regimen as for Varenicline. The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Questionnaire of Smoking Urges and the Alcohol Craving Questionnaire. (This questionnaire is used following visual cue presentation consisting of smoking, drinking and neutral pictures).
Measured: day 1, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startOct 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Laurie Zawertailo, Centre for Addiction and Mental Health
- Investigators
- Usoa E. Busto, Pharm.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873535
- Sponsor's protocol ID
- 114/2008
- Status last verified
- Sep 2015
- First submitted
- 31 Mar 2009
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Acheson A, Mahler SV, Chi H, de Wit H. Differential effects of nicotine on alcohol consumption in men and women. Psychopharmacology (Berl). 2006 May;186(1):54-63. doi: 10.1007/s00213-006-0338-y. Epub 2006 Mar 25.
PubMed 16565827
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Varenicline on Reactivity to Smoking and Drinking Cues in Individuals With Concurrent Tobacco Dependence and Alcohol Use
- ClinicalTrials.gov ID
- NCT00873535
- Acronym / sponsor ID
- 114/2008
- Conditions
- Tobacco Dependence, Alcohol Dependence
- Keywords
- Nicotine, Nicotine dependence, Smoking cessation, Alcohol, Alcohol dependence, Alcohol cessation, Treatment, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 Apr 2009 (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.
Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking. However, very little research has been conducted into the nature of this co-occurrence. Thus, the main aim of this study is to assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking smokers after two weeks treatment of varenicline.
Hypotheses
- Two weeks of varenicline treatment will significantly decrease cue-induced tobacco craving compared to placebo (Due to the actions of varenicline on alpha-4-beta-2 receptors and its downstream effect on dopamine release).
- Varenicline will decrease cue-induced alcohol craving compared to placebo.
- The impact of Varenicline on cue-induced alcohol craving will be greater in heavy drinkers compared to social drinkers.
Detailed description
The relationship between alcohol and tobacco dependence needs to be addressed as such populations are generally excluded from clinical trials involving smoking cessation pharmacotherapy. Furthermore, the effect of Varenicline(Pfizer Pharmaceuticals)treatment on tobacco cue-induced craving has not been empirically measured, nor has the effect of varenicline on alcohol consumption. In addition to being an effective aid in smoking cessation, preliminary evidence has shown that Varenicline can decrease alcohol consumption in animal models.
Varenicline is a partial agonist of the α4β2 nicotinic acetylcholine receptor. This drug's partial agonist effect allows for the activation of this receptor at a lesser degree than nicotine while simultaneously preventing nicotine binding due to the drugs high affinity (i.e.: antagonist effect) for this receptor subtype.
Varenicline has recently been approved in Canada as an aid for smoking cessation. This study will be a double-blind, placebo-controlled randomized study. It will assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking smokers after two weeks of treatment with either varenicline or placebo.Ultimately This study may help to further understand the association between smoking and drinking alcohol.
This study will consist of two study groups composed of 40 subjects each being randomized to receive either placebo or varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). One group will be heavy smokers and heavy drinkers while the other will be heavy smokers and social drinkers. Upon entering the study, subjects will undergo baseline cognitive and craving measures for both tobacco and alcohol associated cue presentations prior to randomization to varenicline or placebo. Subjects will be provided a 1-week supply of study medications and directions for use. During this period, subjects will be requested to complete a diary outlining their cigarette and alcohol craving and consumption each day and outline any adverse effects. Upon completion of this 1-week period, subjects will attend the Centre for Addiction and Mental Health (CAMH) where their old pill bottles and daily diaries will be collected and they will be supplied with study medication (1mg varenicline taken twice daily or placebo) and daily diary for an additional week. At this visit, subjects will complete the symptom checklist. At the end of the second week of treatment, subjects will be requested to return to CAMH where craving for tobacco and alcohol and cue-reactivity will be assessed in a similar manner as to study day After study completion, all subjects will be given the option to continue with varenicline in a 12-week treatment plan through the Nicotine Dependence Clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Active comparator | Drug: VareniclineThis group (N=40) will receive Varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20). |
| Placebo | Placebo comparator | Drug: PlaceboThis group (N=40) will receive placebo in the same dosing regimen as for Varenicline. The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Treatment seeking smokers
- Age 18 to 65 years
- Smoke ≥ 10 cigarettes per day
- Fagerstrom Test of Nicotine Dependence score > 3
- Alcohol Use Disorders Identification Test (AUDIT) > 8
Key exclusion criteria (14 listed)
- Any medical condition requiring immediate investigation or treatment
- Beck Depression Inventory score >16
- Insulin-dependent diabetes
- Drink > 70 standard alcoholic drinks per week for males or drink > 52 standard alcoholic drinks per week for females
- Pregnancy or lactation
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: Chantix, ChampixThis group (N=40) will receive Varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20). | Drug | Varenicline |
| PlaceboThis group (n=40) will receive matching placebo capsules in the identical dosing regimen described for the Varenicline arm. The group will consist of heavy smokers who are heavy drinkers (n=20) and heavy smokers who are social drinkers (n=20). | Drug | Placebo |
Primary outcome
The Questionnaire of Smoking Urges and the Alcohol Craving Questionnaire. (This questionnaire is used following visual cue presentation consisting of smoking, drinking and neutral pictures).
Time frame: day 1, day 14
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 7 Sep 2015.
- Background: PubMed 16565827Acheson A, Mahler SV, Chi H, de Wit H. Differential effects of nicotine on alcohol consumption in men and women. Psychopharmacology (Berl). 2006 May;186(1):54-63. doi: 10.1007/s00213-006-0338-y. Epub 2006 Mar 25.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
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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.
Usoa E. Busto, Pharm.D. principal investigator
Centre for Addiction and Mental Health
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 in people with Tobacco Dependence and Alcohol Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 14 inclusion and 14 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 7 Sep 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 Canada. 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?
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?
The Questionnaire of Smoking Urges and the Alcohol Craving Questionnaire. (This questionnaire is used following visual cue presentation consisting of smoking, drinking and neutral pictures). (time frame: day 1, day 14). 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 NCT00873535, 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 7 Sep 2015.