Trial Outcomes & Findings for S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence (NCT NCT00722124)
NCT ID: NCT00722124
Last Updated: 2011-09-09
Results Overview
7-day point prevalence smoking abstinence biochemically confirmed (expired carbon monoxide \<8ppm)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
150 participants
Primary outcome timeframe
8 weeks
Results posted on
2011-09-09
Participant Flow
Recruitment began on 10/07/08 and completed on 10/01/09. Interested subjects who passed a phone pre-screen were seen at a medical clinic (Mayo Clinic in Rochester, MN and Franciscan Skemp Medical Center in Lacrosse, WI) for consenting and additional study procedures to determine eligibility.
Participant milestones
| Measure |
SAMe 800
Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
|
SAMe 1600
Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
|
Placebo
Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
23
|
26
|
20
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence
Baseline characteristics by cohort
| Measure |
SAMe 800
n=40 Participants
Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
|
SAMe 1600
n=40 Participants
Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
|
Placebo
n=40 Participants
Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
|
Total
n=120 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age Continuous
|
42.1 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
37.0 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
baseline smoking rate
|
19.5 cigarettes per day
STANDARD_DEVIATION 9.3 • n=5 Participants
|
19.9 cigarettes per day
STANDARD_DEVIATION 8.4 • n=7 Participants
|
19.5 cigarettes per day
STANDARD_DEVIATION 8.0 • n=5 Participants
|
19.6 cigarettes per day
STANDARD_DEVIATION 8.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Analysis was performed using intention to treat(ITT). Subjects who discontinued study participation were assumed to be smoking.
7-day point prevalence smoking abstinence biochemically confirmed (expired carbon monoxide \<8ppm)
Outcome measures
| Measure |
SAMe 800
n=40 Participants
|
SAMe 1600
n=40 Participants
|
Placebo
n=40 Participants
|
|---|---|---|---|
|
7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8)
|
7 participants
|
5 participants
|
7 participants
|
Adverse Events
SAMe 800
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
SAMe 1600
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAMe 800
n=40 participants at risk
Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
|
SAMe 1600
n=40 participants at risk
Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
|
Placebo
n=40 participants at risk
Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
|
|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
5.0%
2/40
|
12.5%
5/40
|
2.5%
1/40
|
|
Gastrointestinal disorders
nausea
|
5.0%
2/40
|
5.0%
2/40
|
5.0%
2/40
|
|
General disorders
headache
|
5.0%
2/40
|
0.00%
0/40
|
5.0%
2/40
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/40
|
7.5%
3/40
|
0.00%
0/40
|
|
General disorders
insomnia
|
0.00%
0/40
|
2.5%
1/40
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
anorexia
|
0.00%
0/40
|
2.5%
1/40
|
0.00%
0/40
|
|
General disorders
confusion
|
0.00%
0/40
|
2.5%
1/40
|
0.00%
0/40
|
|
Gastrointestinal disorders
constipation
|
2.5%
1/40
|
0.00%
0/40
|
0.00%
0/40
|
|
General disorders
dizziness
|
0.00%
0/40
|
0.00%
0/40
|
2.5%
1/40
|
|
General disorders
drowsiness/fatigue
|
2.5%
1/40
|
0.00%
0/40
|
0.00%
0/40
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/40
|
2.5%
1/40
|
0.00%
0/40
|
|
Gastrointestinal disorders
heartburn
|
0.00%
0/40
|
2.5%
1/40
|
0.00%
0/40
|
|
General disorders
vivid dreams
|
0.00%
0/40
|
0.00%
0/40
|
2.5%
1/40
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/40
|
2.5%
1/40
|
0.00%
0/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place