Alcohol Drinking
Conditions
Keywords
alcohol, nicotine, smoking cessation, smoking cessation medications
Brief 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.
Interventions
DRUG21mg transdermal nicotine patch (Nicoderm CQ)
21mg transdermal nicotine patch
DRUG1mg nicotine nasal spray
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.
DRUGplacebo nasal spray
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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages 21 and over * Able to read and write in English * Smoker * Heavy drinker
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drinks Consumed During an Ad-libitum Drinking Period | Two hour ad-libitum drinking period during laboratory session | Participants are presented with alcohol beverages and allowed to drink at their leisure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Craving for Alcohol | first measurement during laboratory session (+60 minutes after beginning of laboratory session) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Patch + Nicotine Spray; Nicotine Patch+Placebo Spray Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced.
21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch
1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg)
The nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.
Or
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.
21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch
placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Nicotine Patch + Nicotine Spray; Nicotine Patch+Placebo Spray |
|---|---|
| Age, Continuous | 37.1 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 17 / 22 | 11 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Number of Drinks Consumed During an Ad-libitum Drinking Period
Participants are presented with alcohol beverages and allowed to drink at their leisure.
Time frame: Two hour ad-libitum drinking period during laboratory session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Patch+Nicotine Spray | Number of Drinks Consumed During an Ad-libitum Drinking Period | 1.59 drinks | Standard Deviation 2.24 |
| Nicotine Patch+Placebo Spray | Number of Drinks Consumed During an Ad-libitum Drinking Period | 1.64 drinks | Standard Deviation 2.3 |
Secondary
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.
Time frame: first measurement during laboratory session (+60 minutes after beginning of laboratory session)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Patch+Nicotine Spray | Craving for Alcohol | 14.75 units on a scale | Standard Error 2.1 |
| Nicotine Patch+Placebo Spray | Craving for Alcohol | 17.03 units on a scale | Standard Error 2.33 |