Trial Outcomes & Findings for Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine (NCT NCT01944423)
NCT ID: NCT01944423
Last Updated: 2021-05-19
Results Overview
Smoking status will be assessed at baseline and each of the follow-up assessments using point prevalence abstinence (PPA) measures verified with carbon monoxide and saliva cotinine.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
53 participants
Primary outcome timeframe
Assessed from week 3-29, week 29 reported
Results posted on
2021-05-19
Participant Flow
Participant milestones
| Measure |
PSRT_DCS
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction.
|
PSRT_PBO
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
Pill Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
End of Treatment
|
21
|
20
|
|
Overall Study
1-month Follow-up
|
22
|
19
|
|
Overall Study
4-month Follow-up
|
19
|
16
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine
Baseline characteristics by cohort
| Measure |
PSRT_DCS
n=27 Participants
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction.
|
PSRT_PBO
n=26 Participants
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
Pill Placebo
|
Total
n=53 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
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.19 years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
36.64 years
STANDARD_DEVIATION 12.85 • n=7 Participants
|
35.91 years
STANDARD_DEVIATION 12.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 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
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed from week 3-29, week 29 reportedPopulation: Intent to treat analysis
Smoking status will be assessed at baseline and each of the follow-up assessments using point prevalence abstinence (PPA) measures verified with carbon monoxide and saliva cotinine.
Outcome measures
| Measure |
PSRT_DCS
n=27 Participants
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction.
|
PSRT_PBO
n=26 Participants
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
Pill Placebo
|
|---|---|---|
|
Smoking Abstinence
|
8.25 percentage of participants
|
12.35 percentage of participants
|
SECONDARY outcome
Timeframe: Assessed from week 3-29, week 7 reported (end of treatment)Population: Intent to treat analysis
Anxiety sensitivity was assessed using the Anxiety Sensitivity Index-3, which is an 18 item measure of fear of bodily sensations. Participants rated their concern regarding the possible negative consequences of internal anxiety-related sensations. Scores range from 0-72, with higher scores indicated greater sensitivity to bodily sensations (worse outcome).
Outcome measures
| Measure |
PSRT_DCS
n=27 Participants
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction.
|
PSRT_PBO
n=26 Participants
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
Pill Placebo
|
|---|---|---|
|
Anxiety Sensitivity Mechanistic Target
|
15.37 unstandardized units
Standard Deviation 10.38
|
17.80 unstandardized units
Standard Deviation 13.77
|
SECONDARY outcome
Timeframe: Assessed from week 3-29, week 29 reported (6-month follow-up)Population: Intent to treat analysis
Panic disorder severity scale is a 7-item measure assessing the severity of seven features of panic: frequency of panic attacks, distress during panic attacks, anticipatory anxiety, agoraphobic fear and avoidance, interoceptive fear and avoidance, impairment of work functioning, and impairment of social functioning. Items are rated on a five-point Likert scale ranging from 0 (none) to 4 (extreme), with a total possible score of 28. Higher scores indicate greater severity and impairment.
Outcome measures
| Measure |
PSRT_DCS
n=27 Participants
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction.
|
PSRT_PBO
n=26 Participants
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
Pill Placebo
|
|---|---|---|
|
Panic Symptoms Mechanistic Target
|
5.36 unstandardized units
Standard Deviation 6.96
|
5.40 unstandardized units
Standard Deviation 5.93
|
Adverse Events
PSRT_DCS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PSRT_PBO
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PSRT_DCS
n=27 participants at risk
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
d-cycloserine: d-cycloserine is a medication thought to be associated with fear extinction.
|
PSRT_PBO
n=26 participants at risk
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
Pill Placebo
|
|---|---|---|
|
General disorders
Chipped back bone
|
0.00%
0/27 • Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
|
3.8%
1/26 • Number of events 1 • Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/27 • Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
|
3.8%
1/26 • Number of events 1 • Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/27 • Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
|
3.8%
1/26 • Number of events 1 • Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
|
0.00%
0/26 • Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
|
|
General disorders
Migraine
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
|
0.00%
0/26 • Adverse event data was collected at each in-person appointmnet during the course of the study (baseline appointment through the 6-month follow-up).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place