Alcohol DrinkingPhase 2NCT00699556
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
A Phase 2 study testing 21mg transdermal nicotine patch (Nicoderm CQ) and 1mg nicotine nasal spray in people with Alcohol Drinking, run by Yale University at 1 site in United States.
Trial summary
This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- 21mg transdermal nicotine patch (Nicoderm CQ) and 1mg nicotine nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Nov 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 21 and over
- Able to read and write in English
- Smoker
- Heavy drinker
Who cannot join
- Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol or nicotine
- Significant hepatocellular injury
- Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- Women who are pregnant or nursing
- Suicidal, homicidal, or evidence of severe mental illness
- Prescription of any psychotropic drug in the 30 days prior to study enrollment
Show all 12Show fewer
- Blood donation within the past 8 weeks
- Individuals who are seeking treatment for drinking or smoking who have attempted to quit drinking or smoking within the past 3 months
- Specific exclusions for administration of nicotine nasal spray not specified above including nasal polyps, chronic nasal congestion, allergies, sinusitis
- Specific exclusions for administration of nicotine patch not specified above including history of dermatoses
- Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior adverse reaction to nicotine spray
- Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center & Yale-New Haven Hospital
New Haven, Connecticut, 06519
About this study
This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.
- Conditions
- Alcohol Drinking
- Being tested
- 21mg transdermal nicotine patch (Nicoderm CQ), 1mg nicotine nasal spray, placebo nasal spray
- Keywords
- alcohol, nicotine, smoking cessation, smoking cessation medications
- Medical subject headings
- Alcohol Drinking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
21mg transdermal nicotine patch (Nicoderm CQ)Drug
Also called Nicoderm CQ
21mg transdermal nicotine patch
1mg nicotine nasal sprayDrug
two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.
placebo nasal sprayDrug
saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.
| Study group | Role | What they receive |
|---|---|---|
| patch+spray | Experimental | Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray. Receives: Drug: 21mg transdermal nicotine patch (Nicoderm CQ); Drug: 1mg nicotine nasal spray |
| patch+placebo spray | Placebo comparator | Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray. Receives: Drug: 21mg transdermal nicotine patch (Nicoderm CQ); Drug: placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Drinks Consumed During an Ad-libitum Drinking Period
Participants are presented with alcohol beverages and allowed to drink at their leisure.
Measured: Two hour ad-libitum drinking period during laboratory session
Secondary outcomes (1)
Craving for Alcohol
Alcohol craving was measured using the Alcohol Urge Questionnaire (AUQ). The range of scores is 1-100 on a visual analog scale (VAS). Higher scores indicate higher levels of craving. Score indicated is the total score.
Measured: first measurement during laboratory session (+60 minutes after beginning of laboratory session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJan 2006
- Primary completionNov 2016
- Study completionNov 2016
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 Alcohol DrinkingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 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
- Principal investigator, Sherry McKee, Yale University
- Investigators
- Sherry A McKee, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699556
- Sponsor's protocol ID
- HIC0508000486
- Other IDs
- R01AA015596
- Status last verified
- Feb 2018
- First submitted
- 25 Dec 2007
- Last updated
- 12 Mar 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 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
- ClinicalTrials.gov ID
- NCT00699556
- Acronym / sponsor ID
- HIC0508000486
- Conditions
- Alcohol Drinking
- Keywords
- alcohol, nicotine, smoking cessation, smoking cessation medications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2006
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Posted 12 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patch+spray | Experimental | Drug: 21mg transdermal nicotine patch (Nicoderm CQ), Drug: 1mg nicotine nasal sprayWithin subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray. |
| patch+placebo spray | Placebo comparator | Drug: 21mg transdermal nicotine patch (Nicoderm CQ), Drug: placebo nasal sprayWithin subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 21 and over
- Able to read and write in English
- Smoker
- Heavy drinker
Key exclusion criteria (12 listed)
- Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol or nicotine
- Significant hepatocellular injury
- Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- Women who are pregnant or nursing
- Suicidal, homicidal, or evidence of severe mental illness
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 |
|---|---|---|
| 21mg transdermal nicotine patch (Nicoderm CQ)Also: Nicoderm CQ21mg transdermal nicotine patch | Drug | patch+placebo spray, patch+spray |
| 1mg nicotine nasal spraytwo 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol. | Drug | patch+spray |
| placebo nasal spraysaline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. | Drug | patch+placebo spray |
Primary outcome
Number of Drinks Consumed During an Ad-libitum Drinking Period
Time frame: Two hour ad-libitum drinking period during laboratory session
Participants are presented with alcohol beverages and allowed to drink at their leisure.
1 secondary outcome
Craving for Alcohol
Time frame: first measurement during laboratory session (+60 minutes after beginning of laboratory session)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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.
Sherry A McKee, 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 Phase 2 study testing 21mg transdermal nicotine patch (Nicoderm CQ) and 1mg nicotine nasal spray in people with Alcohol Drinking, 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 12 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 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. 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?
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 12 Mar 2018). 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?
Number of Drinks Consumed During an Ad-libitum Drinking Period (time frame: Two hour ad-libitum drinking period during laboratory session). 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 2018.