Trial Outcomes & Findings for Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2 (NCT NCT00136838)
NCT ID: NCT00136838
Last Updated: 2018-06-18
Results Overview
Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
During Day 4 experimental session
Results posted on
2018-06-18
Participant Flow
Twelve participants were recruited through advertisements in local newspapers and flyers.
Participant milestones
| Measure |
Neutral Cue First, Then Active Cue
Participants receives two consecutive interventions in random order.
1. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
2. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue
|
Active Cue First, Then Neutral Cue
Each participant receives two consecutive interventions in random order.
1. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue
2. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
|
|---|---|---|
|
First Intervention ( 5 Days)
STARTED
|
6
|
6
|
|
First Intervention ( 5 Days)
COMPLETED
|
6
|
6
|
|
First Intervention ( 5 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention ( 5 Days)
STARTED
|
6
|
6
|
|
Second Intervention ( 5 Days)
COMPLETED
|
6
|
6
|
|
Second Intervention ( 5 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2
Baseline characteristics by cohort
| Measure |
Study Participants
n=12 Participants
This is a within-group study design, all participant who completed the study completed 2 phases of treatment, done in random order, each lasting 5 days and separated by at least 2 weeks. During one of the phases participants were exposed to active cigarette cues (pack of cigarettes, smoke) and during the other phase they were exposed to sham control cues (water bottle and the glass)
|
|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During Day 4 experimental sessionFollowing 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices
Outcome measures
| Measure |
Active Cue
n=12 Participants
During this phase participants were exposed to active cigarette cues: pack of cigarettes and a cigarette smoke
|
Neutral Cue
n=12 Participants
During this phase of study participants were exposed to a neutral (sham) cue: a bottle of water and a glass
|
|---|---|---|
|
Cigarette Choice After 3 Day Abstinence
|
2.50 number of cigarette choices (0-6)
Standard Error 0.63
|
3.67 number of cigarette choices (0-6)
Standard Error 0.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: immediately following cue exposeMeasure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving).
Outcome measures
| Measure |
Active Cue
n=12 Participants
During this phase participants were exposed to active cigarette cues: pack of cigarettes and a cigarette smoke
|
Neutral Cue
n=12 Participants
During this phase of study participants were exposed to a neutral (sham) cue: a bottle of water and a glass
|
|---|---|---|
|
Craving
|
58.8 units on a scale (0-70)
Standard Error 3.1
|
53.8 units on a scale (0-70)
Standard Error 5.2
|
Adverse Events
Neutral Cue
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Cue
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