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

Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uma Rao, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00129272
First received: August 4, 2005
Last updated: April 17, 2017
Last verified: April 2017
Results First Received: January 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Tobacco Use Cessation
Tobacco Use Disorder
Interventions: Drug: Bupropion-SR
Other: Placebo

  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
Participants between ages 12 and 25 years who smoked at least 10 cigarettes per day over a period of 6 months were recruited between 2004 and 2010 through advertisements in local newspapers and flyers in local community agencies and primary care clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants completed an assessment for nicotine dependence and psychiatric disorders, and a laboratory stress study to assess baseline salivary cortisol over 2 hours and cortisol responses to a psychosocial stressor (public speaking and arithmetic tasks). Those who continued to meet study criteria were then randomized to active drug or placebo.

Reporting Groups
  Description
Active Drug (Burpropion-SR)

In total 172 participants were recruited, and 144 were randomized.

Using a double-blind, randomized, placebo-controlled design, participants were randomized to active drug or placebo using the modified Efron’s biased coin toss method to ensure that the drug/placebo cells are balanced with respect to severe depression, presence of nicotine dependence symptoms and gender.

Participants received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.

The participants had weekly visits with the target quitting date set for Day 8. The medication checks lasted about 30-45 minutes. The focus was on elicitation of smoking status, nicotine craving and withdrawal symptoms, depressive symptoms and side effects. Body weight and vital signs were measured as well as expired air for CO and urine cotinine levels. Plasma drug levels were obtained at 5 and 9 weeks of treatment.

Matching Placebo

This arm included placebo treatment twice daily for 9 weeks. Drug and placebo were compounded to look identical, masking both drug type and dosage.

All participants (both drug and placebo groups) received a modified version of the brief office intervention program for adolescent smokers, developed by the American Medical Association. Subjects met with a research counselor for 10 consecutive weekly sessions. The initial session (baseline visit) was 60 min. while the remaining sessions were 20-30 min. Each session was individualized to the needs of the adolescent, based on information gathered at the baseline assessment. The brief office intervention materials include checklists and guidelines for each session to assist the counselor in tailoring the session to the needs of the youth. It involved motivational interviewing, incorporating stages of change, peer and parental and other social influences; negative affect and other psychological factors, addiction and self-efficacy.


Participant Flow:   Overall Study
    Active Drug (Burpropion-SR)   Matching Placebo
STARTED   71   73 
COMPLETED   54   51 
NOT COMPLETED   17   22 
Lost to Follow-up                12                11 
Withdrawal by Subject                5                11 



  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.
No text entered.

Reporting Groups
  Description
Active Drug (Bupropion-SR)

Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.

Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks.

Matching Placebo

Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.

Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks.

Total Total of all reporting groups

Baseline Measures
   Active Drug (Bupropion-SR)   Matching Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   73   144 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 19.6  (3.2)   18.3  (3.9)   19.0  (3.6) 
[1] Participants were between 12 and 25 years of age.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      38  53.5%      39  53.4%      77  53.5% 
Male      33  46.5%      34  46.6%      67  46.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Black : non-Hispanic   9   10   19 
Black : Hispanic   0   0   0 
White : non-Hispanic   52   51   103 
White : Hispanic   0   0   0 
More than one race : non-Hispanic   0   0   0 
More than one race : Hispanic   10   12   22 
Region of Enrollment [1] 
[Units: Participants]
     
United States   71   73   144 
[1] The data were collected in Southwestern Region of the United States
Daily smoking diary [1] 
[Units: Cigarettes/day in previous week]
Mean (Standard Deviation)
 17.5  (7.6)   16.4  (6.8)   16.9  (7.2) 
[1] Number of cigarettes smoked per day
Withdrawal symptoms [1] 
[Units: Units on a scale;range 0-36;higher worse]
Mean (Standard Deviation)
 4.3  (3.3)   4.1  (3.5)   4.2  (3.5) 
[1] Hughes-Hatsukami Withdrawal Scale
Nicotine dependence [1] 
[Units: Units on a scale;range 0-9;higher worse]
Mean (Standard Deviation)
 5.6  (1.6)   5.4  (1.3)   5.5  (1.5) 
[1] Fagerstrom Tolerance Questionnaire
Expired carbon monoxide 
[Units: Parts per million; higher worse]
Mean (Standard Deviation)
 13.9  (5.3)   14.0  (8.9)   13.9  (6.9) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Smoking Behavior   [ Time Frame: Nine weeks ]

2.  Secondary:   Withdrawal Symptoms   [ Time Frame: Nine weeks ]


  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: Uma Rao, MD
Organization: The University of Tennessee
phone: 615-794-3351
e-mail: urao@utk.edu



Responsible Party: Uma Rao, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00129272     History of Changes
Other Study ID Numbers: NIDA-15131-1
Study First Received: August 4, 2005
Results First Received: January 16, 2017
Last Updated: April 17, 2017