This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01522963
First received: January 17, 2012
Last updated: June 8, 2017
Last verified: June 2017
Results First Received: February 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: No masking;   Primary Purpose: Other
Condition: Tobacco Use Disorder
Intervention: Drug: Nicotine lozenge

  Participant Flow
  Hide 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 Lozenge Immediately Prior to Stress Task. Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
Nicotine Lozenge 10 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
Nicotine Lozenge 20 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
Nicotine Lozenge 30 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session

Participant Flow:   Overall Study
    Nicotine Lozenge Immediately Prior to Stress Task.   Nicotine Lozenge 10 Min Prior to Stress Task   Nicotine Lozenge 20 Min Prior to Stress Task   Nicotine Lozenge 30 Min Prior to Stress Task
STARTED   24   25   25   24 
COMPLETED   22   22   22   18 
NOT COMPLETED   2   3   3   6 



  Baseline Characteristics
  Hide 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.
Only those that completed the entire cross-over study were included in the analysis

Reporting Groups
  Description
Nicotine Lozenge Immediately Prior to Stress Task. Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
Nicotine Lozenge 10 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session
Nicotine Lozenge 20 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
Nicotine Lozenge 30 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
Total Total of all reporting groups

Baseline Measures
   Nicotine Lozenge Immediately Prior to Stress Task.   Nicotine Lozenge 10 Min Prior to Stress Task   Nicotine Lozenge 20 Min Prior to Stress Task   Nicotine Lozenge 30 Min Prior to Stress Task   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   22   22   18   84 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.2  (10.6)   39.7  (10.9)   38.1  (16.2)   37.9  (14.1)   38.3  (12.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      8  36.4%      10  45.5%      14  63.6%      9  50.0%      41  48.8% 
Male      14  63.6%      12  54.5%      8  36.4%      9  50.0%      43  51.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      1   4.5%      1   4.5%      1   5.6%      3   3.6% 
Asian      0   0.0%      1   4.5%      0   0.0%      0   0.0%      1   1.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      7  31.8%      8  36.4%      4  18.2%      1   5.6%      20  23.8% 
White      14  63.6%      11  50.0%      16  72.7%      14  77.8%      55  65.5% 
More than one race      1   4.5%      0   0.0%      1   4.5%      1   5.6%      3   3.6% 
Unknown or Not Reported      0   0.0%      1   4.5%      0   0.0%      1   5.6%      2   2.4% 
Region of Enrollment 
[Units: Participants]
         
United States   22   22   22   18   84 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Craving   [ Time Frame: 5 to 35 minutes ]

2.  Primary:   Nicotine Withdrawal Symptoms   [ Time Frame: 5 to 35 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: Michael Kotlyar
Organization: University of Minnesota
phone: 6126251160
e-mail: kotly001@umn.edu



Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01522963     History of Changes
Other Study ID Numbers: DA029689
R21DA029689 ( U.S. NIH Grant/Contract )
Study First Received: January 17, 2012
Results First Received: February 13, 2017
Last Updated: June 8, 2017