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Trial Outcomes & Findings for Combining a Smoke Ending Aid With Behavioral Treatment - 1 (NCT NCT00006151)

NCT ID: NCT00006151

Last Updated: 2015-12-03

Results Overview

The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

1 year

Results posted on

2015-12-03

Participant Flow

Participants were recruited to a university based center for the study of addictions in 2002.

The study used a real world design meaning that participants were randomized on the same day as their study eligibility evaluation.

Participant milestones

Participant milestones
Measure
Accu Drops (AD&C)
The experimental group (N=30) will be prescribed active Accu Drops (AD\&C)
Placebo (PD&C)
The control condition (N=30) will be prescribed placebo Accu Drops (PD\&C)
Overall Study
STARTED
30
30
Overall Study
COMPLETED
17
16
Overall Study
NOT COMPLETED
13
14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combining a Smoke Ending Aid With Behavioral Treatment - 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Accu Drop Plus Counseling
n=30 Participants
Active product and systematic cigarette tapering plus counseling.
Placebo Accu Drop Plus Counseling
n=30 Participants
Placebo product and systematic cigarette tapering plus counseling
Total
n=60 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
n=93 Participants
30 Participants
n=4 Participants
60 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Continuous
47.07 years
STANDARD_DEVIATION 11.4 • n=93 Participants
43.50 years
STANDARD_DEVIATION 12 • n=4 Participants
45.29 years
STANDARD_DEVIATION 11.7 • n=27 Participants
Sex: Female, Male
Female
17 Participants
n=93 Participants
20 Participants
n=4 Participants
37 Participants
n=27 Participants
Sex: Female, Male
Male
13 Participants
n=93 Participants
10 Participants
n=4 Participants
23 Participants
n=27 Participants
Region of Enrollment
United States
30 participants
n=93 Participants
30 participants
n=4 Participants
60 participants
n=27 Participants

PRIMARY outcome

Timeframe: 1 year

The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.

Outcome measures

Outcome measures
Measure
Accu Drop Plus Counseling
n=30 Participants
Active product and systematic cigarette tapering plus counseling.
Placebo Accu Drop Plus Counseling
n=30 Participants
Placebo product and systematic cigarette tapering plus counseling
Abstinence Rate
3 participants
4 participants

Adverse Events

Accu Drops (AD&C)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo (PD&C)

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

Peter Gariti

University of Pennsylvania

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place