Trial Outcomes & Findings for Smokers' Response to Nicotine Dependence Genotyping (NCT NCT01780038)
NCT ID: NCT01780038
Last Updated: 2024-10-31
Results Overview
Abstinence: Point-Prevalence \& Continuous Self-Report; Exhaled Carbon Monoxide (CO): \<= 6 ppm past 24 hrs.; Salivary Cotinine: \<15 ng/ml past 7 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Assessed at Weeks 6 and 10 after Genotyping Results, Week 10 reported
Results posted on
2024-10-31
Participant Flow
A total of 169 persons contacted the study coordinator (n = 169). Of these, 63 were lost to follow-up due to non-return of phone call when contacted. A total of 43 participants completed the assessment for eligibility. Of these 19 were excluded (7 did not meet the criteria and 12 declined to participate further). A total of 24 participants were randomized, 12 each to the experimental and control groups.
Participant milestones
| Measure |
Receipt of Genetic Results
Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730
Receipt of Genetic Results: Participants will receive the results of genotyping for RS1051730
|
No Results Given
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
No results given: Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Receipt of Genetic Results
Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730
Receipt of Genetic Results: Participants will receive the results of genotyping for RS1051730
|
No Results Given
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
No results given: Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
Smokers' Response to Nicotine Dependence Genotyping
Baseline characteristics by cohort
| Measure |
Receipt of Genetic Results
n=12 Participants
Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730
Receipt of Genetic Results: Participants will receive the results of genotyping for RS1051730
|
No Results Given
n=12 Participants
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
No results given: Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at Weeks 6 and 10 after Genotyping Results, Week 10 reportedAbstinence: Point-Prevalence \& Continuous Self-Report; Exhaled Carbon Monoxide (CO): \<= 6 ppm past 24 hrs.; Salivary Cotinine: \<15 ng/ml past 7 days
Outcome measures
| Measure |
Receipt of Genetic Results
n=8 Participants
Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730
Receipt of Genetic Results: Participants will receive the results of genotyping for RS1051730
|
No Results Given
n=11 Participants
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
No results given: Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
|
|---|---|---|
|
Change in Baseline Smoking Abstinence at 6 and 10 Weeks After Genotyping Results
Total Achieving Cessation
|
1 Participants
|
0 Participants
|
|
Change in Baseline Smoking Abstinence at 6 and 10 Weeks After Genotyping Results
Total Still Smoking
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Assessed at Weeks 6 and 10 weeks after Genotyping Results, Week 10 reported.Use of Pharmacotherapy: Self-report of type and frequency of use of FDA-approved smoking cessation medications.
Outcome measures
| Measure |
Receipt of Genetic Results
n=8 Participants
Receipt of Genetic Results indicates that participants have received the results of genotyping for RS1051730
Receipt of Genetic Results: Participants will receive the results of genotyping for RS1051730
|
No Results Given
n=11 Participants
Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
No results given: Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
|
|---|---|---|
|
Change in Baseline Use of Pharmacotherapy at 6 and 10 Weeks After Genotyping Results
Pharmacotherapy use
|
2 Participants
|
2 Participants
|
|
Change in Baseline Use of Pharmacotherapy at 6 and 10 Weeks After Genotyping Results
No pharmacotherapy use
|
6 Participants
|
9 Participants
|
Adverse Events
Receipt of Genetic Results
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Results Given
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place