Cigarette SmokingEarly Phase 1NCT02193256
Varenicline + Prazosin for Heavy Drinking Smokers
A Early Phase 1 study testing Varenicline and Prazosin in people with Cigarette Smoking and Alcohol Use Disorders, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of varenicline and prazosin on smoking, drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an FDA approved smoking cessation medication. Some smokers report sleep problems when taking varenicline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking, Alcohol Use Disorders
- What is being tested?
- Varenicline and Prazosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jun 2015
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age;
- current smoker [quantity of ≥ cigarettes per smoking day, frequency of ≥3 times per week, and urinary cotinine ≥2 on NicAlert dipstick;
- at least 4 occasions of heavy drinking in the past 30 days [5 or 4 standard drinks per occasion for males and females, respectively];
- no history of severe alcohol withdrawal syndrome;
- no new onset of psychiatric illness or psychotropic medications in last 90 days;
- no severe psychiatric illness [schizophrenia, bipolar disorder] or PTSD;
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- no substance dependence other than nicotine, alcohol or marijuana;
- no medical contraindications for varenicline or prazosin;
- are willing to take medication and wear portable sleep monitoring devices;
- no risk for sleep apnea syndrome;
- able to read and write in English;
- not interested in quitting smoking immediately.
Who cannot join
- unable to complete the informed consent;
- do not meet criteria for heavy drinking;
- do not meet criteria for current smokers;
- unable to read/understand English;
- exhibit serious psychiatric illness (i.e. schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder), organic mood or mental disorders by history of psychological examination;
- meet criteria for alcohol dependence in past 12 months that is clinically severe;
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- meet criteria for drug dependence in the last 12 months aside from marijuana, nicotine and alcohol;
- are seeking to quit smoking immediately;
- report current psychosis or suicidality;
- are a female of childbearing potential who is pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide);
- exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:
- any unexplained elevations in liver enzymes (i.e. transaminases, bilirubin);
- clinically significant, unstable cardiovascular disease/uncontrolled hypertension;
- hepatic or renal impairment;
- severe obstructive pulmonary disease;
- diabetes mellitus requiring insulin or certain oral medications (i.e. sulfonylureas) and an A1C hemoglobin test score of >7 for participants not prescribed these medications;
- baseline systolic blood pressure higher than 150 mm Hg of diastolic blood pressure higher than 95 mm Hg; (g) are scheduled for cataract surgery; (h) have a diagnosis of narcolepsy;
- have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin)
- have a history of clinically significant allergic reactions;
- have used any psychotropic drug in the past month, except individuals who are on a stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months;
- intend to donate blood or blood products during the treatment phase of the study;
- have a Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 28 or weight less than 45 kg.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06511
About this study
Official title: Pilot Trial of Varenicline and Prazosin to Treat Heavy Drinking Smokers
The purpose of this study is to examine the effect of varenicline and prazosin on smoking, drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an FDA approved smoking cessation medication. Some smokers report sleep problems when taking varenicline. This study will test whether using prazosin, which is an FDA-approved blood pressure medication, in combination with varenicline reduces sleep problems that can be associated with using varenicline for smoking cessation. In addition, the study will examine the combined effects of these medications on smoking and drinking.
Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone prior to the 3-day practice quit attempt.
Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone during the 3-day practice quit attempt.
Read the detailed description
The study comprises an 8-week double-blind, within-subjects, crossover design of varenicline (up to 2mg per day) plus either prazosin (up to 8mg per day) (V+P) or placebo (V) with 20 heavy drinking smokers. Each medication phase is 3 weeks with a 2-week medication washout in between. Participants are asked to make a practice quit attempt for 3 days the last week of each medication phase.
This is an exploratory study to look at two primary aims:
- Evaluate the effect of prazosin on sleep disturbance caused by varenicline in heavy drinking smokers prior to quitting smoking. Hypothesis: V+P will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than V alone.
- Evaluate the effect of prazosin on sleep disturbance caused by varenicline during smoking cessation in heavy drinking smokers.
Hypothesis: V+P will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than V alone We will also investigate the combined effects of prazosin and varenicline on smoking behavior (i.e., smoking urge) and alcohol consumption (i.e., drinks per drinking day) as exploratory aims.
- Conditions
- Cigarette Smoking, Alcohol Use Disorders
- Being tested
- Varenicline, Prazosin, Placebo
- Keywords
- varenicline, prazosin, cigarette smoking, alcohol drinking, sleep, dreams
- Medical subject headings
- Cigarette Smoking, Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
Titrated over 1 week to a maximum dose of 2mg/day
PrazosinDrug
Also called Minipress
Titrated over 3 weeks to a maximum dose of 8mg/day
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Varenicline plus Prazosin | Active comparator | Varenicline: .5mg for 3 days then 1mg daily for 4 days (Week 1) then 2mg daily thereafter (Weeks 2-3). Prazosin: 1mg for 3 days, then 3mg for 4 days (Week 1), (2) 6mg for 3 days, then 8mg for 4 days (Week 2), and (3) 8mg (Week 3). Receives: Drug: Varenicline; Drug: Prazosin |
| Varenicline plus Placebo | Placebo comparator | Varenicline: .5mg for 3 days then 1mg daily for 4 days (Week 1) then 2mg daily thereafter (Weeks 2-3). Placebo: placebo will be given instead of prazosin (Weeks 1-3) Receives: Drug: Varenicline; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of prazosin on sleep disturbance caused by varenicline prior to quitting smoking
Sleep disturbance will be measured using self-report questionnaires (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Pittsburgh Sleep Diary, Dream Quality Questionnaire) and objective sleep-monitoring devices.
Measured: Two weeks
Effect of prazosin on sleep disturbance caused by varenicline during smoking cessation
Sleep disturbance will be measured using self-report questionnaires (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Pittsburgh Sleep Diary, Dream Quality Questionnaire) and objective sleep-monitoring devices.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Lisa M Fucito, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193256
- Sponsor's protocol ID
- 1402013410
- Other IDs
- K05AA014715
- Status last verified
- Mar 2020
- First submitted
- 14 Jul 2014
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Varenicline and Prazosin to Treat Heavy Drinking Smokers
- ClinicalTrials.gov ID
- NCT02193256
- Acronym / sponsor ID
- 1402013410
- Conditions
- Cigarette Smoking, Alcohol Use Disorders
- Keywords
- varenicline, prazosin, cigarette smoking, alcohol drinking, sleep, dreams
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Jul 2014 (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.
The purpose of this study is to examine the effect of varenicline and prazosin on smoking, drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an FDA approved smoking cessation medication. Some smokers report sleep problems when taking varenicline. This study will test whether using prazosin, which is an FDA-approved blood pressure medication, in combination with varenicline reduces sleep problems that can be associated with using varenicline for smoking cessation. In addition, the study will examine the combined effects of these medications on smoking and drinking.
Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone prior to the 3-day practice quit attempt.
Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone during the 3-day practice quit attempt.
Detailed description
The study comprises an 8-week double-blind, within-subjects, crossover design of varenicline (up to 2mg per day) plus either prazosin (up to 8mg per day) (V+P) or placebo (V) with 20 heavy drinking smokers. Each medication phase is 3 weeks with a 2-week medication washout in between. Participants are asked to make a practice quit attempt for 3 days the last week of each medication phase.
This is an exploratory study to look at two primary aims:
- Evaluate the effect of prazosin on sleep disturbance caused by varenicline in heavy drinking smokers prior to quitting smoking. Hypothesis: V+P will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than V alone.
- Evaluate the effect of prazosin on sleep disturbance caused by varenicline during smoking cessation in heavy drinking smokers.
Hypothesis: V+P will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than V alone We will also investigate the combined effects of prazosin and varenicline on smoking behavior (i.e., smoking urge) and alcohol consumption (i.e., drinks per drinking day) as exploratory aims.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline plus Prazosin | Active comparator | Drug: Varenicline, Drug: PrazosinVarenicline: .5mg for 3 days then 1mg daily for 4 days (Week 1) then 2mg daily thereafter (Weeks 2-3). Prazosin: 1mg for 3 days, then 3mg for 4 days (Week 1), (2) 6mg for 3 days, then 8mg for 4 days (Week 2), and (3) 8mg (Week 3). |
| Varenicline plus Placebo | Placebo comparator | Drug: Varenicline, Drug: PlaceboVarenicline: .5mg for 3 days then 1mg daily for 4 days (Week 1) then 2mg daily thereafter (Weeks 2-3). Placebo: placebo will be given instead of prazosin (Weeks 1-3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- at least 18 years of age;
- current smoker [quantity of ≥ cigarettes per smoking day, frequency of ≥3 times per week, and urinary cotinine ≥2 on NicAlert dipstick;
- at least 4 occasions of heavy drinking in the past 30 days [5 or 4 standard drinks per occasion for males and females, respectively];
- no history of severe alcohol withdrawal syndrome;
- no new onset of psychiatric illness or psychotropic medications in last 90 days;
Key exclusion criteria (22 listed)
- unable to complete the informed consent;
- do not meet criteria for heavy drinking;
- do not meet criteria for current smokers;
- unable to read/understand English;
- exhibit serious psychiatric illness (i.e. schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder), organic mood or mental disorders by history of psychological examination;
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: ChantixTitrated over 1 week to a maximum dose of 2mg/day | Drug | Varenicline plus Placebo, Varenicline plus Prazosin |
| PrazosinAlso: MinipressTitrated over 3 weeks to a maximum dose of 8mg/day | Drug | Varenicline plus Prazosin |
| Placebo | Drug | Varenicline plus Placebo |
Primary outcome
Effect of prazosin on sleep disturbance caused by varenicline prior to quitting smoking
Time frame: Two weeks
Sleep disturbance will be measured using self-report questionnaires (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Pittsburgh Sleep Diary, Dream Quality Questionnaire) and objective sleep-monitoring devices.
Effect of prazosin on sleep disturbance caused by varenicline during smoking cessation
Time frame: One week
Sleep disturbance will be measured using self-report questionnaires (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Pittsburgh Sleep Diary, Dream Quality Questionnaire) and objective sleep-monitoring devices.
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 12 Mar 2020.
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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.
Lisa M Fucito, PhD 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 Early Phase 1 study testing Varenicline and Prazosin in people with Cigarette Smoking and Alcohol Use Disorders, 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 12 inclusion and 22 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 12 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Effect of prazosin on sleep disturbance caused by varenicline prior to quitting smoking (time frame: Two weeks). The study lists 2 primary outcomes in all. 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 12 Mar 2020.