Post-traumatic Stress DisorderNCT00923923
Stress Reactivity in Veterans Receiving Pharmacological Treatment for PTSD and Alcohol Dependence
A study testing stress in people with Post-traumatic Stress Disorder and Alcohol Dependence, run by Yale University at 1 site in United States.
Trial summary
Method: This study is designed as an accompaniment to an already funded study - a 12-week treatment trial with prazosin for patients with PTSD and AD. The study design will consist of III phases. In phase I, all subjects will participate in three laboratory sessions to determine their reactivity to stress. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Post-traumatic Stress Disorder, Alcohol Dependence
- What is being tested?
- stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female patients age 21 to 65.
- current diagnosis of DSM-IV PTSD (determined by SCID and CAPS and AD (determine by SCID)).
- participants who drink regularly (determined by TLFB and recorded 90 days prior to the interview), and are not abstinent for more than 2 weeks before participation in the study.
- are not in an active phase of alcohol withdrawal.
- are not at risk for suicide.
Who cannot join
- current SCID diagnosis of any psychotic disorder.
- history of substance dependence (other than alcohol and nicotine) in the last 30 days.
- current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology (LFT 5 times normal, abnormal BUN and creatinine, and unmanaged hypertension with BP > 200/120) which in the opinion of the physician would preclude the patient from fully cooperating or be of potential harm during the course of the study.
- taking medication for a psychiatric condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healtcase System
West Haven, Connecticut, 06516
About this study
Official title: Stress Reactivity in Veterans Receiving Pharmacological Treatment for Post-traumatic Stress Disorder (PTSD) and Alcohol Dependence
Method: This study is designed as an accompaniment to an already funded study - a 12-week treatment trial with prazosin for patients with PTSD and AD.
The study design will consist of III phases. In phase I, all subjects will participate in three laboratory sessions to determine their reactivity to stress. Stress reactivity will be measured using: traumatic experiences, stressful non-trauma experiences and neutral experiences, presented randomly. Laboratory sessions will be conducted in an outpatient setting. Phase II is a randomized clinical trial evaluating prazosin versus placebo for 12 weeks in a double-blind, controlled fashion in an outpatient setting. The treatment will last for 12 weeks and outcomes will include symptoms of PTSD and alcohol use. In phase III, subjects will again participate in a laboratory session. This phase of the study will be conducted after at least 6 weeks of treatment while patients are on medication (prazosin or placebo).
Read more
Hypotheses:
Primary: The investigators hypothesize that prazosin will be more effective than placebo in reducing trauma-related stress reactivity in a laboratory paradigm, particularly anxiety, craving for alcohol, and hormonal response, in individuals with PTSD and AD.
Secondary: The investigators hypothesize that stress reactivity will have a moderating effect on treatment with prazosin, such that individuals with high levels of stress reactivity will have fewer heavy drinking days, a significant reduction in PTSD symptoms, and shorter time to relapse than individuals with low levels of stress reactivity.
Read the detailed description
Specific Aim: We propose a laboratory study that will examine stress reactivity as a marker for treatment response to prazosin in patients with PTSD and AD.
Background: Increasing evidence shows that PTSD and AD are both associated with abnormalities in stress reactivity. In PTSD, the increase in hormonal response and subjective increases in affective symptoms provide evidence for abnormalities in stress reactivity. In AD, significant increases in craving after stressful stimuli and alcohol cues point to abnormalities in stress response. There is increasing evidence that these laboratory paradigms are clinically relevant and may be useful in predicting treatment outcomes in patients with substance use disorders. Stress induced craving has been used as a marker for relapse. Individuals with greater stress reactivity have a shorter time to relapse to their preferred substance than individuals with lesser stress reactivity.
Attenuation of trauma-related distress may be effective in reducing both craving and negative affect in individuals with PTSD and AD. In a very elegant study, Coffey and his colleagues (Coffey et al, 2006) found that imaginal exposure therapy was more effective than relaxation alone in reducing craving for alcohol after exposure to stressful imagery and alcohol cues. However, it should be noted that interventions such as imaginal exposure therapy target only symptoms of PTSD, have to be administered by highly trained professionals and have to be provided in specialized settings.
We propose a laboratory study that will test whether pharmacotherapy that targets both symptoms of PTSD and AD can attenuate the stress response, and how the attenuation of stress response will affect relapse and outcome.
Method: This study is designed as an accompaniment to an already funded study by the DOD - a 12-week treatment trial with prazosin for patients with PTSD and AD. The current proposal will augment the findings from the treatment study and identify for which patients prazosin may be effective. It is important to note that this study is very different from the PTSD Coop study in that study EXCLUDES individuals with alcohol dependence. The DOD study and this companion study will provide answers relevant to alcohol use, alcohol relapse and drinking outcomes.
The study design will consist of III phases. In phase I, all subjects will participate in three laboratory sessions to determine their reactivity to stress. Stress reactivity will be measured using: traumatic experiences, stressful non-trauma experiences and neutral experiences, presented randomly. Laboratory sessions will be conducted in an inpatient setting. Phase II is a randomized clinical trial evaluating prazosin versus placebo for 12 weeks in a double-blind, controlled fashion in an outpatient setting. The treatment will last for 12 weeks and outcomes will include symptoms of PTSD and alcohol use. In phase III, subjects will again be admitted to an inpatient unit. This phase of the study will be conducted during the 12th and final week on medication while participants are still receiving prazosin or placebo.
Hypotheses: Primary: We hypothesize that prazosin will be more effective than placebo in reducing trauma-related stress reactivity in a laboratory paradigm, particularly anxiety, craving for alcohol, and hormonal response, in individuals with PTSD and AD. And this will be a marker for treatment response to prazosin in patient with PTSD and AD.
Secondary: We hypothesize that stress reactivity will have a moderating effect on treatment with prazosin, such that individuals with high levels of stress reactivity will have fewer heavy drinking days, a significant reduction in PTSD symptoms, and shorter time to relapse than individuals with low levels of stress reactivity.
- Conditions
- Post-traumatic Stress Disorder, Alcohol Dependence
- Being tested
- stress
- Keywords
- stress reactivity, PTSD, alcohol dependence, drinking, craving
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stressBehavioural
compare levels of stress
| Study group | Role | What they receive |
|---|---|---|
| levels of stress | Experimental | Not described Receives: Behavioral: stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety, craving for alcohol and hormone levels
Measured: 12 weeks
Secondary outcomes (1)
treatment efficacy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Ralevski, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923923
- Sponsor's protocol ID
- HIC # 0806003974
- Other IDs
- HSS # ER0005
- Status last verified
- Dec 2016
- First submitted
- 12 Jun 2009
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ralevski E, Southwick S, Jackson E, Jane JS, Russo M, Petrakis I. Trauma- and Stress-Induced Response in Veterans with Alcohol Dependence and Comorbid Post-Traumatic Stress Disorder. Alcohol Clin Exp Res. 2016 Aug;40(8):1752-60. doi: 10.1111/acer.13120. Epub 2016 Jul 1.
PubMed 27368085
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reactivity in Veterans Receiving Pharmacological Treatment for Post-traumatic Stress Disorder (PTSD) and Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00923923
- Acronym / sponsor ID
- HIC # 0806003974
- Conditions
- Post-traumatic Stress Disorder, Alcohol Dependence
- Keywords
- stress reactivity, PTSD, alcohol dependence, drinking, craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Method: This study is designed as an accompaniment to an already funded study - a 12-week treatment trial with prazosin for patients with PTSD and AD.
The study design will consist of III phases. In phase I, all subjects will participate in three laboratory sessions to determine their reactivity to stress. Stress reactivity will be measured using: traumatic experiences, stressful non-trauma experiences and neutral experiences, presented randomly. Laboratory sessions will be conducted in an outpatient setting. Phase II is a randomized clinical trial evaluating prazosin versus placebo for 12 weeks in a double-blind, controlled fashion in an outpatient setting. The treatment will last for 12 weeks and outcomes will include symptoms of PTSD and alcohol use. In phase III, subjects will again participate in a laboratory session. This phase of the study will be conducted after at least 6 weeks of treatment while patients are on medication (prazosin or placebo).
Hypotheses:
Primary: The investigators hypothesize that prazosin will be more effective than placebo in reducing trauma-related stress reactivity in a laboratory paradigm, particularly anxiety, craving for alcohol, and hormonal response, in individuals with PTSD and AD.
Secondary: The investigators hypothesize that stress reactivity will have a moderating effect on treatment with prazosin, such that individuals with high levels of stress reactivity will have fewer heavy drinking days, a significant reduction in PTSD symptoms, and shorter time to relapse than individuals with low levels of stress reactivity.
Detailed description
Specific Aim: We propose a laboratory study that will examine stress reactivity as a marker for treatment response to prazosin in patients with PTSD and AD.
Background: Increasing evidence shows that PTSD and AD are both associated with abnormalities in stress reactivity. In PTSD, the increase in hormonal response and subjective increases in affective symptoms provide evidence for abnormalities in stress reactivity. In AD, significant increases in craving after stressful stimuli and alcohol cues point to abnormalities in stress response. There is increasing evidence that these laboratory paradigms are clinically relevant and may be useful in predicting treatment outcomes in patients with substance use disorders. Stress induced craving has been used as a marker for relapse. Individuals with greater stress reactivity have a shorter time to relapse to their preferred substance than individuals with lesser stress reactivity.
Attenuation of trauma-related distress may be effective in reducing both craving and negative affect in individuals with PTSD and AD. In a very elegant study, Coffey and his colleagues (Coffey et al, 2006) found that imaginal exposure therapy was more effective than relaxation alone in reducing craving for alcohol after exposure to stressful imagery and alcohol cues. However, it should be noted that interventions such as imaginal exposure therapy target only symptoms of PTSD, have to be administered by highly trained professionals and have to be provided in specialized settings.
We propose a laboratory study that will test whether pharmacotherapy that targets both symptoms of PTSD and AD can attenuate the stress response, and how the attenuation of stress response will affect relapse and outcome.
Method: This study is designed as an accompaniment to an already funded study by the DOD - a 12-week treatment trial with prazosin for patients with PTSD and AD. The current proposal will augment the findings from the treatment study and identify for which patients prazosin may be effective. It is important to note that this study is very different from the PTSD Coop study in that study EXCLUDES individuals with alcohol dependence. The DOD study and this companion study will provide answers relevant to alcohol use, alcohol relapse and drinking outcomes.
The study design will consist of III phases. In phase I, all subjects will participate in three laboratory sessions to determine their reactivity to stress. Stress reactivity will be measured using: traumatic experiences, stressful non-trauma experiences and neutral experiences, presented randomly. Laboratory sessions will be conducted in an inpatient setting. Phase II is a randomized clinical trial evaluating prazosin versus placebo for 12 weeks in a double-blind, controlled fashion in an outpatient setting. The treatment will last for 12 weeks and outcomes will include symptoms of PTSD and alcohol use. In phase III, subjects will again be admitted to an inpatient unit. This phase of the study will be conducted during the 12th and final week on medication while participants are still receiving prazosin or placebo.
Hypotheses: Primary: We hypothesize that prazosin will be more effective than placebo in reducing trauma-related stress reactivity in a laboratory paradigm, particularly anxiety, craving for alcohol, and hormonal response, in individuals with PTSD and AD. And this will be a marker for treatment response to prazosin in patient with PTSD and AD.
Secondary: We hypothesize that stress reactivity will have a moderating effect on treatment with prazosin, such that individuals with high levels of stress reactivity will have fewer heavy drinking days, a significant reduction in PTSD symptoms, and shorter time to relapse than individuals with low levels of stress reactivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| levels of stress | Experimental | Behavioral: stress |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male and female patients age 21 to 65.
- current diagnosis of DSM-IV PTSD (determined by SCID and CAPS and AD (determine by SCID)).
- participants who drink regularly (determined by TLFB and recorded 90 days prior to the interview), and are not abstinent for more than 2 weeks before participation in the study.
- are not in an active phase of alcohol withdrawal.
- are not at risk for suicide.
Key exclusion criteria (4 listed)
- current SCID diagnosis of any psychotic disorder.
- history of substance dependence (other than alcohol and nicotine) in the last 30 days.
- current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology (LFT 5 times normal, abnormal BUN and creatinine, and unmanaged hypertension with BP > 200/120) which in the opinion of the physician would preclude the patient from fully cooperating or be of potential harm during the course of the study.
- taking medication for a psychiatric condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stresscompare levels of stress | Behavioural | levels of stress |
Primary outcome
Anxiety, craving for alcohol and hormone levels
Time frame: 12 weeks
1 secondary outcome
treatment efficacy
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Results publication: PubMed 27368085Ralevski E, Southwick S, Jackson E, Jane JS, Russo M, Petrakis I. Trauma- and Stress-Induced Response in Veterans with Alcohol Dependence and Comorbid Post-Traumatic Stress Disorder. Alcohol Clin Exp Res. 2016 Aug;40(8):1752-60. doi: 10.1111/acer.13120. Epub 2016 Jul 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Ralevski, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress in people with Post-traumatic Stress Disorder and Alcohol Dependence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety, craving for alcohol and hormone levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00923923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.