Effects of Naltrexone on Nicotine Reinforcement

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00270231
First received: December 23, 2005
Last updated: November 12, 2013
Last verified: November 2013
Results First Received: February 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator)
Condition: Tobacco Dependence
Interventions: Drug: Naltrexone
Drug: 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
Recruitment occurred from March 2004 to August 2005. All subject sessions occurred at the Tobacco Use Research Center's lab, the Biobehavioral Lab (BBL), at the University of Pennsylvania.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The primary genotype of interest was the functional mu opioid receptor (OPRM1). Smokers with the Asp40 variant (A/G or G/G genotypes; about 27% of smokers) were oversampled, relative to those with the more common Asn40 variant (A/A genotype; 73% of smokers), in order to have an equal number of participants in each genotype group.

Reporting Groups
  Description
Naltrexone, Then Placebo

These participants took active naltrexone during their first 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg.

They received placebo (sugar pill) during the second 4-day study period.

Placebo, Then Naltrexone

These participants took placebo (sugar pill) during their first 4-day study period.

They received active naltrexone during the second 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg.


Participant Flow for 3 periods

Period 1:   First Intervention
    Naltrexone, Then Placebo     Placebo, Then Naltrexone  
STARTED     32     32  
COMPLETED     31     31  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 1  

Period 2:   Washout Period
    Naltrexone, Then Placebo     Placebo, Then Naltrexone  
STARTED     31     31  
COMPLETED     30     31  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  

Period 3:   Second Intervention
    Naltrexone, Then Placebo     Placebo, Then Naltrexone  
STARTED     30     31  
COMPLETED     30     30  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  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
Entire Study Population Includes subjects with both OPRM1 genotypes (Asp40 (A/G or G/G allele vs. Asn40 (A/A) allele) who started Intervention Period 1.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  64  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     59  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  43.2  ± 15.0  
Gender  
[units: participants]
 
Female     26  
Male     38  
Region of Enrollment  
[units: participants]
 
United States     64  



  Outcome Measures

1.  Primary:   Number of Nicotine Cigarette Choices Taken During the Cigarette Choice Procedure.   [ Time Frame: 2 hours ]


  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: Caryn Lerman, Ph.D.
Organization: University of Pennsylvania
phone: 215-746-7141
e-mail: clerman@mail.med.upenn.edu


Publications of Results:
Other Publications:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00270231     History of Changes
Other Study ID Numbers: 800810, R01DA017555
Study First Received: December 23, 2005
Results First Received: February 18, 2009
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration