Trial Outcomes & Findings for Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention (NCT NCT02896712)
NCT ID: NCT02896712
Last Updated: 2023-02-08
Results Overview
Urine is assessed for levels of the cocaine metabolite benzoylecgonine (BE), and the drug screen is considered positive for cocaine use if BE level is ≥ 150 ng/mL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
4 weeks
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only
This arm included participants who responded to ACT plus CM in phase 1, as well as participants who did not proceed to receive modafinil or placebo in phase 2.
In phase 1 (weeks 1-4), ACT plus CM for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
In phase 2 (weeks 5-12), ACT plus CM for cocaine use will continue to be administered.
|
ACT Plus CM, With Placebo
This arm included participants who did not respond to ACT plus CM in phase 1 and who proceeded to receive placebo in phase 2.
In phase 1 (weeks 1-4), ACT plus CM for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
In phase 2 (weeks 5-12), ACT plus CM for cocaine use will continue to be administered and participants will also receive placebo.
|
ACT Plus CM, With Modafinil
This arm included participants who did not respond to ACT plus CM in phase 2 and who proceeded to receive modafinil in phase 2.
In phase 1 (weeks 1-4), ACT plus CM for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
In phase 2 (weeks 5-12), ACT plus CM for cocaine use will continue to be administered and participants will also receive modafinil.
|
Drug Counseling (DC) Plus Contingency Management (CM) Only
This arm included participants who responded to DC plus CM in phase 1, as well as participants who did not proceed to receive modafinil or placebo in phase 2.
In phase 1 (weeks 1-4), DC plus CM for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
In phase 2 (weeks 5-12), DC plus CM for cocaine use will continue to be administered.
|
DC Plus CM, With Placebo
This arm included participants who did not respond to DC plus CM in phase 1 and who proceeded to receive placebo in phase 2.
In phase 1 (weeks 1-4), DC plus CM for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
In phase 2 (weeks 5-12), DC plus CM for cocaine use will continue to be administered and participants will also receive placebo.
|
DC Plus CM, With Modafinil
This arm included participants who did not respond to DC plus CM in phase 1 and who proceeded to receive modafinil in phase 2.
In phase 1 (weeks 1-4), DC plus CM for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
In phase 2 (weeks 5-12), DC plus CM for cocaine use will continue to be administered and participants will also receive modafinil.
|
|---|---|---|---|---|---|---|
|
Phase 1
STARTED
|
18
|
17
|
19
|
21
|
23
|
20
|
|
Phase 1
COMPLETED
|
14
|
17
|
19
|
10
|
23
|
20
|
|
Phase 1
NOT COMPLETED
|
4
|
0
|
0
|
11
|
0
|
0
|
|
Phase 2
STARTED
|
14
|
17
|
19
|
10
|
23
|
20
|
|
Phase 2
COMPLETED
|
8
|
11
|
10
|
9
|
13
|
13
|
|
Phase 2
NOT COMPLETED
|
6
|
6
|
9
|
1
|
10
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention
Baseline characteristics by cohort
| Measure |
Phase 1: ACT Plus CM
n=54 Participants
Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
|
Phase 1: DC Plus CM
n=64 Participants
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.48 years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
51.58 years
STANDARD_DEVIATION 6.58 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 7.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
106 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 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
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
64 participants
n=7 Participants
|
118 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Using a modified intention-to-treat plan, data are reported for all participants who completed at least one visit after randomization.
Urine is assessed for levels of the cocaine metabolite benzoylecgonine (BE), and the drug screen is considered positive for cocaine use if BE level is ≥ 150 ng/mL.
Outcome measures
| Measure |
Phase 1: ACT Plus CM
n=627 visits
Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
|
Phase 1: DC Plus CM
n=648 visits
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
ACT Plus CM, With Modafinil
Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
|
DC Plus CM
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
DC Plus CM, With Placebo
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12).
|
DC Plus CM, With Modafinil
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
|
|---|---|---|---|---|---|---|
|
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
|
0.31 proportion of visits
Standard Deviation 0.36
|
0.24 proportion of visits
Standard Deviation 0.34
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Data are reported for all participants who started phase 2.
Urine is assessed for levels of the cocaine metabolite benzoylecgonine (BE), and the drug screen is considered positive for cocaine use if BE level is ≥ 150 ng/mL.
Outcome measures
| Measure |
Phase 1: ACT Plus CM
n=486 visits
Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
|
Phase 1: DC Plus CM
n=593 visits
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
ACT Plus CM, With Modafinil
n=703 visits
Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
|
DC Plus CM
n=349 visits
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
DC Plus CM, With Placebo
n=808 visits
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12).
|
DC Plus CM, With Modafinil
n=701 visits
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
|
|---|---|---|---|---|---|---|
|
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
|
0.67 proportion of visits
Standard Deviation 0.24
|
0.22 proportion of visits
Standard Deviation 0.24
|
0.12 proportion of visits
Standard Deviation 0.12
|
0.70 proportion of visits
Standard Deviation 0.32
|
0.12 proportion of visits
Standard Deviation 0.15
|
0.10 proportion of visits
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Using a modified intention-to-treat plan, data are reported for all participants who completed at least one visit after randomization.
Timeline Followback (TLFB) is a method to assess of cocaine use that involves asking study participants to self-report their cocaine use over the past week.
Outcome measures
| Measure |
Phase 1: ACT Plus CM
n=53 Participants
Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
|
Phase 1: DC Plus CM
n=57 Participants
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
ACT Plus CM, With Modafinil
Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
|
DC Plus CM
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
DC Plus CM, With Placebo
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12).
|
DC Plus CM, With Modafinil
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
|
|---|---|---|---|---|---|---|
|
Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
|
0.70 proportion of days
Standard Deviation 0.23
|
0.66 proportion of days
Standard Deviation 0.27
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Data are reported for all participants who started phase 2.
Timeline Followback (TLFB) is a method to assess of cocaine use that involves asking study participants to self-report their cocaine use over the past week.
Outcome measures
| Measure |
Phase 1: ACT Plus CM
n=14 Participants
Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
|
Phase 1: DC Plus CM
n=17 Participants
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
ACT Plus CM, With Modafinil
n=19 Participants
Acceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
|
DC Plus CM
n=10 Participants
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
DC Plus CM, With Placebo
n=23 Participants
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12).
|
DC Plus CM, With Modafinil
n=20 Participants
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
|
|---|---|---|---|---|---|---|
|
Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
|
0.83 proportion of days
Standard Deviation 0.10
|
0.58 proportion of days
Standard Deviation 0.31
|
0.70 proportion of days
Standard Deviation 0.16
|
0.88 proportion of days
Standard Deviation 0.11
|
0.63 proportion of days
Standard Deviation 0.27
|
0.64 proportion of days
Standard Deviation 0.27
|
Adverse Events
Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Phase 2: ACT Plus CM Only
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 2: ACT Plus CM, With Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase 2: ACT Plus CM, With Modafinil
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 2: DC Plus CM Only
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: DC Plus CM, With Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase 2: DC Plus CM, With Modafinil
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only
n=54 participants at risk
In phase 1 (weeks 1-4), ACT plus CM for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
|
Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only
n=64 participants at risk
In phase 1 (weeks 1-4), DC plus CM for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
Phase 2: ACT Plus CM Only
n=14 participants at risk
In phase 2 (weeks 5-12), ACT plus CM for cocaine use will continue to be administered.
|
Phase 2: ACT Plus CM, With Placebo
n=17 participants at risk
In phase 2 (weeks 5-12), ACT plus CM for cocaine use will continue to be administered and participants will also receive placebo.
|
Phase 2: ACT Plus CM, With Modafinil
n=19 participants at risk
In phase 2 (weeks 5-12), ACT plus CM for cocaine use will continue to be administered and participants will also receive modafinil.
|
Phase 2: DC Plus CM Only
n=10 participants at risk
In phase 2 (weeks 5-12), DC plus CM for cocaine use will continue to be administered.
|
Phase 2: DC Plus CM, With Placebo
n=23 participants at risk
In phase 2 (weeks 5-12), DC plus CM for cocaine use will continue to be administered and participants will also receive placebo.
|
Phase 2: DC Plus CM, With Modafinil
n=20 participants at risk
In phase 2 (weeks 5-12), DC plus CM for cocaine use will continue to be administered and participants will also receive modafinil.
|
|---|---|---|---|---|---|---|---|---|
|
Social circumstances
Domestic Violence/Abuse
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Gastrointestinal disorders
Stomach Flu
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Attack
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Symptoms of Congestive Heart Failure
|
0.00%
0/54 • 12 weeks
|
1.6%
1/64 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
5.0%
1/20 • Number of events 2 • 12 weeks
|
Other adverse events
| Measure |
Phase 1: Acceptance and Commitment Therapy (ACT) Plus Contingency Management (CM) Only
n=54 participants at risk
In phase 1 (weeks 1-4), ACT plus CM for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
|
Phase 1: Drug Counseling (DC) Plus Contingency Management (CM) Only
n=64 participants at risk
In phase 1 (weeks 1-4), DC plus CM for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
|
Phase 2: ACT Plus CM Only
n=14 participants at risk
In phase 2 (weeks 5-12), ACT plus CM for cocaine use will continue to be administered.
|
Phase 2: ACT Plus CM, With Placebo
n=17 participants at risk
In phase 2 (weeks 5-12), ACT plus CM for cocaine use will continue to be administered and participants will also receive placebo.
|
Phase 2: ACT Plus CM, With Modafinil
n=19 participants at risk
In phase 2 (weeks 5-12), ACT plus CM for cocaine use will continue to be administered and participants will also receive modafinil.
|
Phase 2: DC Plus CM Only
n=10 participants at risk
In phase 2 (weeks 5-12), DC plus CM for cocaine use will continue to be administered.
|
Phase 2: DC Plus CM, With Placebo
n=23 participants at risk
In phase 2 (weeks 5-12), DC plus CM for cocaine use will continue to be administered and participants will also receive placebo.
|
Phase 2: DC Plus CM, With Modafinil
n=20 participants at risk
In phase 2 (weeks 5-12), DC plus CM for cocaine use will continue to be administered and participants will also receive modafinil.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Drowsiness
|
0.00%
0/54 • 12 weeks
|
1.6%
1/64 • Number of events 4 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
5.9%
1/17 • Number of events 1 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
10.0%
2/20 • Number of events 5 • 12 weeks
|
|
General disorders
Not Sleeping Well
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
3.1%
2/64 • Number of events 3 • 12 weeks
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
11.8%
2/17 • Number of events 4 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
4.3%
1/23 • Number of events 2 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
General disorders
Headache
|
3.7%
2/54 • Number of events 2 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
11.8%
2/17 • Number of events 3 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
General disorders
Nervousness
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
5.9%
1/17 • Number of events 1 • 12 weeks
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Eye disorders
Blurry Vision
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
10.0%
2/20 • Number of events 3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • Number of events 2 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/54 • 12 weeks
|
1.6%
1/64 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Gastrointestinal disorders
Stomach Pain
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
3.1%
2/64 • Number of events 2 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
11.8%
2/17 • Number of events 2 • 12 weeks
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
10.0%
2/20 • Number of events 6 • 12 weeks
|
|
Cardiac disorders
Heart Racing
|
0.00%
0/54 • 12 weeks
|
1.6%
1/64 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
General disorders
Chest Pain
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
1.6%
1/64 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54 • Number of events 1 • 12 weeks
|
3.1%
2/64 • Number of events 3 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
5.9%
1/17 • Number of events 2 • 12 weeks
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
4.3%
1/23 • Number of events 10 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Renal and urinary disorders
Increased Urination
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
5.9%
1/17 • Number of events 12 • 12 weeks
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
General disorders
Change in Sexual Function
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
General disorders
Weakness
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
10.0%
2/20 • Number of events 2 • 12 weeks
|
|
General disorders
Sweating
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
8.7%
2/23 • Number of events 2 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
General disorders
Dry Mouth
|
0.00%
0/54 • 12 weeks
|
1.6%
1/64 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
General disorders
Fatigue
|
0.00%
0/54 • 12 weeks
|
1.6%
1/64 • Number of events 3 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
5.3%
1/19 • Number of events 3 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
10.0%
2/20 • Number of events 9 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Difficulty Walking
|
0.00%
0/54 • 12 weeks
|
1.6%
1/64 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
5.0%
1/20 • Number of events 7 • 12 weeks
|
|
General disorders
Swelling
|
0.00%
0/54 • 12 weeks
|
0.00%
0/64 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
4.3%
1/23 • Number of events 2 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Cardiac disorders
Loss of Appetite
|
0.00%
0/54 • 12 weeks
|
1.6%
1/64 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/23 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
Additional Information
Joy Schmitz, PhD
The University of Texas Health Science Center at Houston
Phone: 713-486-2867
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place