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

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ClinicalTrials.gov Identifier: NCT00699556
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sherry McKee, Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alcohol Drinking
Interventions: Drug: 21mg transdermal nicotine patch (Nicoderm CQ)
Drug: 1mg nicotine nasal spray
Drug: placebo nasal spray

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow for 2 periods

Period 1:   First Intervention (1 Day)
    Nicotine Patch+Spray First, Then Nicotine Patch+Placebo Spray   Nicotine Patch+Placebo Spray First, Then Nicotine Patch+Spray
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   0 

Period 2:   Second Intervention (1 Day)
    Nicotine Patch+Spray First, Then Nicotine Patch+Placebo Spray   Nicotine Patch+Placebo Spray First, Then Nicotine Patch+Spray
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Baseline Measures
   Nicotine Patch + Nicotine Spray; Nicotine Patch+Placebo Spray 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.1  (10.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  22.7% 
Male      17  77.3% 


  Outcome Measures

1.  Primary:   Number of Drinks Consumed During an Ad-libitum Drinking Period   [ Time Frame: Two hour ad-libitum drinking period during laboratory session ]

2.  Secondary:   Craving for Alcohol   [ Time Frame: first measurement during laboratory session (+60 minutes after beginning of laboratory session) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sherry McKee
Organization: Yale University
phone: (203) 737-3529
e-mail: sherry.mckee@yale.edu



Responsible Party: Sherry McKee, Yale University
ClinicalTrials.gov Identifier: NCT00699556     History of Changes
Other Study ID Numbers: HIC0508000486
R01AA015596 ( U.S. NIH Grant/Contract )
First Submitted: December 25, 2007
First Posted: June 18, 2008
Results First Submitted: November 20, 2017
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018