Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether the drug prazosin is effective for the treatment of alcohol dependency and symptoms of Posttraumatic Stress Disorder (PTSD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Background: Alcohol dependence (AD) is a biologically, genetically based disease, yet the majority of clinically accepted treatments are behaviorally or psychosocially based. PTSD and alcohol use disorders (AUDs) commonly co-occur. This comorbidity is associated with more severe clinical impairment, shorter times to relapse, more treatment recidivism, overall greater use of treatment services, and greater treatment costs.
Neuropharmacology of alcohol and prazosin: Emerging pre-clinical evidence shows that noradrenergic systems are involved in brain processes relevant to AD, such as arousal, reinforcement, and stress responsivity. However, virtually no work to date has attempted to translate this knowledge into clinically effective biological interventions. The investigators have adopted the novel, promising strategy of reducing adrenergic activity by blocking noradrenaline binding to post-synaptic alpha-1 receptors via the non-selective, alpha-1 antagonist, prazosin. Preclinical studies have demonstrated that prazosin decreases reinstatement of alcohol consumption, and preliminary clinical data suggest that prazosin reduces alcohol use in humans with AD and reduces PTSD-related nightmares and other symptoms, though it has not been tested in individuals with comorbid AD and PTSD. Prazosin, FDA approved to treat hypertension, typically has few side effects, and is inexpensive.
Design: Randomized double-blind placebo-controlled clinical trial. Participants: 60 individuals with both AD and PTSD (25% women) with stated goal to abstain from alcohol use.
Intervention: Either prazosin titrated per study protocol or matched placebo for 6 weeks with Medical Management (MM) based on the COMBINE Study procedures and a final study visit two weeks after medication discontinuation.
Measures: The primary outcomes are alcohol use during the 12-week medication phase of the study and reports of craving during the same time period. Daily, prompted Interactive Voice Response (IVR) telephone monitoring will be done throughout the 8-week study to assess the primary outcomes and to provide information on affect and medication adherence. Such daily monitoring provides more accurate reports of alcohol use than standard retrospective outcome measures. Analyses: Hierarchical linear modeling to test for main effects of prazosin+MM versus placebo+MM on alcohol use and PTSD symptoms over time, and to evaluate whether reductions in PTSD mediate the effect of prazosin.
Findings to date: Participants randomized to prazosin had a greater reduction in percent days drinking per week and percent days heavy drinking per week between baseline and week 6 than did placebo participants. No significant differences were detected within or between groups in change from weeks 1 to 6 in total PTSD symptoms. Participants in the prazosin condition reported drowsiness on significantly more days than those in the placebo condition. Public health implications: There is a paucity of safe, tolerable, inexpensive, and efficacious drugs currently available for the treatment of AD and PTSD. Consistent with the extant research evaluating medications for comorbid PTSD/AD, the current evaluation of prazosin also found decreased alcohol consumption but no medication effect on PTSD symptomatology.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prazosin Prazosin medication |
Drug: Prazosin
Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
Other Names:
|
| Placebo Comparator: Placebo Placebo medication |
Drug: Placebo medication
Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percent Drinking Days Per Week [6 weeks]
Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The percentage of drinking days of each participant was calculated by summing the number of drinking days and comparing them with the number of total drinking days in the same week. The percentage of drinking days from each week was added and averaged to get the percentage of drinking days per week per participant. The percentage of drinking days of all participants in the Prazosin group was added and averaged to get the mean of the percentage of weekly drinking days of the Prazosin group. These steps were repeated for the Placebo group.
- Percent Heavy Drinking Days Per Week [6 weeks]
Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. Heavy drinking was defined as 5 or more drinks per day for men and 4 or more drinks per day for women. The percentage of heavy drinking days of each participant was calculated by summing the number of heavy drinking days and comparing them with the total number of drinking days in the same week. The percentage of heavy drinking days from each week was added and averaged to get the percentage of heavy drinking days per week per participant. The percentage of heavy drinking days of all participants in the Prazosin group was added and averaged to get the mean of percentage of weekly heavy drinking days of the Prazosin group. These steps were repeated for the Placebo group.
- Total Drinks Per Week [6 weeks]
Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The weekly total drinks of each participant were calculated by adding the number of drinks by week. The total drinks from each week were added and averaged to get the weekly total drinks of each participant. The weekly total drinks of all participants in the Prazosin group were added and averaged to get the total drinks per week for the Prazosin group. These steps were repeated for the Placebo group.
Secondary Outcome Measures
- PTSD Symptom Assessments [6 weeks]
PTSD symptoms/changes in PTSD (Post-Traumatic Stress Disorder) symptomatology was calculated using data from the IVR (interactive Voice Response) monitoring. PTSD scores were derived by computing the daily average of the item totals for overall PTSD and the symptom clusters. The rating range was 0 (not at all) to 8 (extremely). The higher the score/rating, the more severe the PTSD symptoms. The lowest and highest possible average are 0 and 8, respectively.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Current primary DSM-IV diagnosis of alcohol dependence(AD)
-
Current DSM-IV diagnosis of PTSD
-
At least 14 (women) or 21 (men) drinks per week AND at least 2 days of heavy drinking during a consecutive 30 day period in the last 90 days
-
Desire to abstain from drinking
-
At least 18 years of age
-
Good general medical health (see Exclusion Criteria below)
-
Capacity to provide informed consent
-
English fluency
Exclusion Criteria:
Psychiatric/behavioral:
-
psychiatric disorder requiring any medication other than anti-depressants (individuals not on a stable dose of an anti-depressant for at least 30 days prior to randomization will be excluded from the study)
-
currently taking disulfiram, acamprosate, or naltrexone in the last 30 days or planning to take any of these medications during the 12-week medication phase of the study
-
acutely suicidal or homicidal
-
current dependence on any other psychoactive substance other than nicotine or cannabis
-
a current diagnosis of opioid abuse, use of any opioid- containing medications, methamphetamines, or benzodiazepines during the previous month, or UDA positive for opioids, methamphetamines, benzodiazepines, or sedative hypnotics
Medical:
-
significant acute or chronic medical illness including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic <110) or orthostatic hypotension (defined as a systolic drop > 20mmHg after two minutes standing or any drop with dizziness); insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo, narcolepsy
-
for males only, concomitant use of trazodone (or use in the last 7 days), tadalafil, or vardenafil (or use in the last 3 days) due to increased risk of priapism
-
history of prazosin-sensitivity; no prazosin for at least the past 30 days
-
women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the study physician or PA to be effective
-
signs or symptoms of alcohol withdrawal at the time of initial consent
-
legal involvement that could interfere with study treatment
-
individuals court ordered for treatment will not be eligible to participate in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Puget Sound Health Care System | Seattle | Washington | United States | 98108 |
Sponsors and Collaborators
- Seattle Institute for Biomedical and Clinical Research
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- VA Puget Sound Health Care System
Investigators
- Principal Investigator: Tracy L Simpson, PhD, VA Puget Sound Health Care System
Study Documents (Full-Text)
More Information
Publications
None provided.- P20AA017839
- 1P20AA017839-01
Study Results
Participant Flow
| Recruitment Details | Participant were recruited from September 2009 to June 2012 (2 years and 9 months). Out of 354 people who inquired about the study, 30 were eligible and randomized. |
|---|---|
| Pre-assignment Detail | Out of 354 individuals who inquired about the study, 54 consented and completed the in-person screen. Out of these 54 individuals, 2 declined participation and 22 were ineligible: 10 individuals did not have PTSD and the rest had an acute illness (4), uncontrolled psychosis (2), legal involvement (2), and other reasons not previously mentioned (4). |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Prazosin medication Prazosin: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg | Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg |
| Period Title: Overall Study | ||
| STARTED | 15 | 15 |
| COMPLETED | 9 | 11 |
| NOT COMPLETED | 6 | 4 |
Baseline Characteristics
| Arm/Group Title | Prazosin | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Prazosin medication Prazosin: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg | Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg | Total of all reporting groups |
| Overall Participants | 15 | 15 | 30 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
43.1
(11.3)
|
43.5
(12.4)
|
43.3
(11.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
40%
|
5
33.3%
|
11
36.7%
|
| Male |
9
60%
|
10
66.7%
|
19
63.3%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
8
53.3%
|
4
26.7%
|
12
40%
|
| Black |
4
26.7%
|
8
53.3%
|
12
40%
|
| Other |
3
20%
|
3
20%
|
6
20%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
15
100%
|
15
100%
|
30
100%
|
| Number of Drinks per Day, 90 Days Prior to Baseline (drinks per day) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [drinks per day] |
11
(10.8)
|
8.5
(5.1)
|
9.75
(8.4)
|
| Total Drinks, 7 Days Prior to Baseline (total drinks per week) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [total drinks per week] |
80.1
(75.1)
|
49.6
(44.6)
|
64.85
(62.6)
|
| Number of Drinking Days, 7 Days Prior to Baseline (drinking days per week) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [drinking days per week] |
5.1
(1.7)
|
4.2
(2.8)
|
4.65
(2.3)
|
| Baseline Alcohol Craving Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
22.1
(4.5)
|
17.5
(6.8)
|
19.8
(6.1)
|
| Baseline PTSD (Post-Traumatic Stress Disorder) Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
31.5
(8.9)
|
31.6
(7.7)
|
31.55
(8.2)
|
Outcome Measures
| Title | Percent Drinking Days Per Week |
|---|---|
| Description | Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The percentage of drinking days of each participant was calculated by summing the number of drinking days and comparing them with the number of total drinking days in the same week. The percentage of drinking days from each week was added and averaged to get the percentage of drinking days per week per participant. The percentage of drinking days of all participants in the Prazosin group was added and averaged to get the mean of the percentage of weekly drinking days of the Prazosin group. These steps were repeated for the Placebo group. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent drinking days per week was examined using multilevel mixed-effects linear regression models with random slope that included treatment group, time, & treatment group x time interaction. Time was modeled as a categorical variable. |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Prazosin medication Prazosin: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg | Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg |
| Measure Participants | 9 | 11 |
| Mean (95% Confidence Interval) [percentage of drinking days per week] |
18.1
|
49.3
|
| Title | Percent Heavy Drinking Days Per Week |
|---|---|
| Description | Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. Heavy drinking was defined as 5 or more drinks per day for men and 4 or more drinks per day for women. The percentage of heavy drinking days of each participant was calculated by summing the number of heavy drinking days and comparing them with the total number of drinking days in the same week. The percentage of heavy drinking days from each week was added and averaged to get the percentage of heavy drinking days per week per participant. The percentage of heavy drinking days of all participants in the Prazosin group was added and averaged to get the mean of percentage of weekly heavy drinking days of the Prazosin group. These steps were repeated for the Placebo group. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent heavy drinking days per week was examined using multilevel mixed-effects linear regression models with random slope that included treatment group, time, & treatment group x time interaction. Time was modeled as a categorical variable. |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Prazosin medication Prazosin: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg | Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg |
| Measure Participants | 9 | 11 |
| Mean (95% Confidence Interval) [Percentage of heavy drinking days/week] |
3.7
|
27.4
|
| Title | Total Drinks Per Week |
|---|---|
| Description | Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The weekly total drinks of each participant were calculated by adding the number of drinks by week. The total drinks from each week were added and averaged to get the weekly total drinks of each participant. The weekly total drinks of all participants in the Prazosin group were added and averaged to get the total drinks per week for the Prazosin group. These steps were repeated for the Placebo group. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The total number of drinks per week was examined using multilevel mixed-effects linear regression models with random slope that included treatment group, time, & treatment group x time interaction. Time was modeled as a categorical variable. |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Prazosin medication Prazosin: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg | Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg |
| Measure Participants | 9 | 11 |
| Mean (95% Confidence Interval) [drinks per week] |
7.9
|
27
|
| Title | PTSD Symptom Assessments |
|---|---|
| Description | PTSD symptoms/changes in PTSD (Post-Traumatic Stress Disorder) symptomatology was calculated using data from the IVR (interactive Voice Response) monitoring. PTSD scores were derived by computing the daily average of the item totals for overall PTSD and the symptom clusters. The rating range was 0 (not at all) to 8 (extremely). The higher the score/rating, the more severe the PTSD symptoms. The lowest and highest possible average are 0 and 8, respectively. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| PTSD outcomes between weeks 1 and 6 were analyzed using multilevel mixed-effects linear regression models. Models were adjusted for baseline PTSD severity as measured by corresponding PSS-I scores & sub-scores because measures comparable to the IVR PTSD measures were not available at baseline. Analyses were also adjusted for gender. |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Prazosin medication Prazosin: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg | Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg |
| Measure Participants | 9 | 11 |
| Total PTSD score |
3.1
|
2.5
|
| Re-experiencing |
3.2
|
2.6
|
| Avoidance/numbing |
2.9
|
2.4
|
| Hypervigilance |
3.2
|
2.4
|
| Disturbung dreams |
2.5
|
2.8
|
Adverse Events
| Time Frame | The collection of adverse event data started after the first participant was enrolled in early July of 2010. All participants completed their participation by the end of June 2012. Each participant's adverse events were monitored for about 1 to 12 weeks, depending whether they completed the study or not. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Study clinician check participants for adverse events (AE's) on medication day 2, twice weekly during the dose titration phase (days 1-14), & weekly during the continuation phase (days 15-84) through physical examinations, an open-ended question, and an Adverse Symptom Checklist. Two participants who were withdrawn by the study staff were excluded, thus there were only 14 total participants/group in the all-cause mortality, serious AE's, and other AE's. | |||
| Arm/Group Title | Placebo | Prazosin | ||
| Arm/Group Description | Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg | Prazosin medication Prazosin: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg | ||
All Cause Mortality |
||||
| Placebo | Prazosin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/14 (0%) | ||
Serious Adverse Events |
||||
| Placebo | Prazosin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/14 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo | Prazosin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/14 (100%) | 10/14 (71.4%) | ||
| General disorders | ||||
| Experienced 1 adverse event | 2/14 (14.3%) | 0/14 (0%) | ||
| Experienced 2 adverse events | 5/14 (35.7%) | 1/14 (7.1%) | ||
| Experienced 3 adverse events | 7/14 (50%) | 9/14 (64.3%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Tracy L. Simpson, Ph.D. |
|---|---|
| Organization | VA Puget Sound Health Care System |
| Phone | 206-277-3337 |
| tracy.simpson@va.gov |
- P20AA017839
- 1P20AA017839-01