Trial Outcomes & Findings for D-cycloserine (DCS) Pretreatment + CBT + Nicotine Replacement Therapy for Smoking Cessation (DCS) (NCT NCT01842334)
NCT ID: NCT01842334
Last Updated: 2018-08-31
Results Overview
Cigarette smoking at 10 weeks as measured by carbon monoxide levels and self-report measurements.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
During Week 10
Results posted on
2018-08-31
Participant Flow
9 out of the 21 subject screened did not qualify for randomization. 6 of the subjects were no longer interested in participating after the screening visit, 2 did not return repeated phone calls by study staff and 1 subject did not qualify due to being on probation.
Participant milestones
| Measure |
D-cycloserine
250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.
Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.
Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.
|
Placebo
one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy
Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.
Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
D-cycloserine
250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.
Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.
Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.
|
Placebo
one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy
Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.
Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Moved away mid-study
|
0
|
1
|
Baseline Characteristics
D-cycloserine (DCS) Pretreatment + CBT + Nicotine Replacement Therapy for Smoking Cessation (DCS)
Baseline characteristics by cohort
| Measure |
D-cycloserine
n=5 Participants
250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.
Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.
Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.
|
Placebo
n=7 Participants
one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy
Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.
Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 6.96 • n=5 Participants
|
39.57 years
STANDARD_DEVIATION 15.79 • n=7 Participants
|
35.58 years
STANDARD_DEVIATION 13.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Baseline Cigs/Day
|
13.34 cigarettes/day
STANDARD_DEVIATION 2.18 • n=5 Participants
|
12.87 cigarettes/day
STANDARD_DEVIATION 2.01 • n=7 Participants
|
13.04 cigarettes/day
STANDARD_DEVIATION 1.97 • n=5 Participants
|
PRIMARY outcome
Timeframe: During Week 10Population: Only the 5 completers of this study who made it to week 10 could have this measure analyzed.
Cigarette smoking at 10 weeks as measured by carbon monoxide levels and self-report measurements.
Outcome measures
| Measure |
D-cycloserine
n=2 Participants
250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.
Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.
Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.
|
Placebo
n=3 Participants
one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy
Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.
Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.
|
|---|---|---|
|
Change From Baseline in Cigarette Smoking in Treatment Seeking Nicotine Dependent Outpatients
|
2.57 Cigarettes/day
Standard Deviation 3.63
|
0.29 Cigarettes/day
Standard Deviation 0.25
|
Adverse Events
D-cycloserine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
D-cycloserine
n=5 participants at risk
250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.
Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.
Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.
|
Placebo
n=7 participants at risk
one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy
Cognitive Behavioral Therapy: CBT administered to to both DCS and placebo group.
Nicotine Replacement Therapy: NRT administered to both DCS and placebo group.
|
|---|---|---|
|
General disorders
Nausea due to Nicotine Patch
|
20.0%
1/5 • Number of events 1 • Adverse even data was collected from the baseline visit until the end of the study (14 weeks after baseline)
|
0.00%
0/7 • Adverse even data was collected from the baseline visit until the end of the study (14 weeks after baseline)
|
Additional Information
Dr. Kevin P Hill, Director of the Division of Addiction Psychiatry
Beth Israel Deaconess Medical Center
Phone: 617-667-1504
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place