Trial Outcomes & Findings for Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy (NCT NCT00699556)

NCT ID: NCT00699556

Last Updated: 2018-03-12

Results Overview

Participants are presented with alcohol beverages and allowed to drink at their leisure.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: Two hour ad-libitum drinking period during laboratory session
• Results posted on: 2018-03-12

Participant Flow

Participant milestones

Measure	Nicotine Patch+Spray First, Then 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.	Nicotine Patch+Placebo Spray First, Then Nicotine Patch+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.
First Intervention (1 Day) STARTED	11	11
First Intervention (1 Day) COMPLETED	11	11
First Intervention (1 Day) NOT COMPLETED	0	0
Second Intervention (1 Day) STARTED	11	11
Second Intervention (1 Day) COMPLETED	11	11
Second Intervention (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy

Baseline characteristics by cohort

Measure	Nicotine Patch + Nicotine Spray; Nicotine Patch+Placebo Spray n=22 Participants 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.
Age, Continuous	37.1 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Two hour ad-libitum drinking period during laboratory session

Participants are presented with alcohol beverages and allowed to drink at their leisure.

Outcome measures

Measure	Nicotine Patch+Nicotine Spray n=22 Participants Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray. 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 at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.	Nicotine Patch+Placebo Spray n=22 Participants 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 The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.
Number of Drinks Consumed During an Ad-libitum Drinking Period	1.59 drinks Standard Deviation 2.24	1.64 drinks Standard Deviation 2.30

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Nicotine Patch+Nicotine Spray n=22 Participants Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray. 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 at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.	Nicotine Patch+Placebo Spray n=22 Participants 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 The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.
Craving for Alcohol	14.75 units on a scale Standard Error 2.10	17.03 units on a scale Standard Error 2.33

Adverse Events

Patch+Spray

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Patch+Placebo Spray

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Patch+Spray n=22 participants at risk Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray. 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 at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.	Patch+Placebo Spray n=22 participants at risk 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 The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.
General disorders Skin Irritation	4.5% 1/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.	0.00% 0/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.
Cardiac disorders Heart rate > 100	4.5% 1/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.	4.5% 1/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.
General disorders Dizziness/light headed	18.2% 4/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.	13.6% 3/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.
Gastrointestinal disorders Nausea	0.00% 0/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.	0.00% 0/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.
General disorders Abdominal discomfort	4.5% 1/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.	0.00% 0/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.
General disorders Nasal irritation	77.3% 17/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.	50.0% 11/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.
General disorders Throat irritation	59.1% 13/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.	4.5% 1/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.
General disorders Eyes watering	77.3% 17/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.	45.5% 10/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.
General disorders hands or feet cold	4.5% 1/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.	9.1% 2/22 • During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.

Additional Information

Sherry McKee

Yale University

Phone: (203) 737-3529

Email: sherry.mckee@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place