Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/29/2018 |
| Start Date: | November 2014 |
| End Date: | November 2018 |
| Contact: | Kimberley Hodge, B.A. |
| Phone: | 206-277-4872 |
Effect of Prazosin and Naltrexone on Personalized Script-Induced Alcohol Craving in Individuals With Alcohol Use Disorders With and Without Comorbid PTSD
The purpose of this study is to see whether the drugs prazosin and naltrexone will decrease
alcohol cravings and drinking in individuals who have problems with alcohol and have used
alcohol at risky levels in the past 90 days.
Prazosin is a medication that is FDA approved for treating people with high blood pressure.
Some studies have shown that prazosin may also decrease nightmares and improve sleep in
Veterans suffering from Posttraumatic Stress Disorder (PTSD). The use of prazosin for PTSD
nightmares is an off-label use. That means that the FDA has not approved prazosin for PTSD
nightmares. The current study is evaluating an "off-label" use of prazosin to determine
whether it is helpful in decreasing alcohol cravings and consumption among people with
alcohol problems.
Naltrexone is a medication that is FDA approved for treating alcohol problems.
This study is sponsored by the Department of Defense and the Congressionally Directed Medical
Research Program (DoD/CDMRP). We expect approximately 240 participants in this study, which
will run over approximately 4 years. Study participants will be involved in the study for 7
weeks, or until they complete the Final Assessment.
alcohol cravings and drinking in individuals who have problems with alcohol and have used
alcohol at risky levels in the past 90 days.
Prazosin is a medication that is FDA approved for treating people with high blood pressure.
Some studies have shown that prazosin may also decrease nightmares and improve sleep in
Veterans suffering from Posttraumatic Stress Disorder (PTSD). The use of prazosin for PTSD
nightmares is an off-label use. That means that the FDA has not approved prazosin for PTSD
nightmares. The current study is evaluating an "off-label" use of prazosin to determine
whether it is helpful in decreasing alcohol cravings and consumption among people with
alcohol problems.
Naltrexone is a medication that is FDA approved for treating alcohol problems.
This study is sponsored by the Department of Defense and the Congressionally Directed Medical
Research Program (DoD/CDMRP). We expect approximately 240 participants in this study, which
will run over approximately 4 years. Study participants will be involved in the study for 7
weeks, or until they complete the Final Assessment.
In the context of the proposed double-blind, double-dummy, placebo controlled study of
prazosin and naltrexone participants will undergo two craving inductions, one oriented
towards relief craving and the other towards reward craving. Daily IVR (Interactive Voice
Recording System) data on craving and consumption and PTSD symptomatology will be collected
during the 7 days immediately following the initial assessment visit to establish a
pre-medication baseline. One hundred twenty individuals with adequate IVR compliance and
whose screening lab tests indicate it is safe for them to take the study medications will
enter the medication phase of the study within 14 days of the initial assessment initiating
prazosin/placebo as well as 50mg naltrexone/placebo treatment. Randomization will be blocked
by gender, PTSD status, and desire to abstain vs. desire to cut down. Prazosin will be
titrated to three times daily dosing (9 am: 4mg; 3pm: 4 mg; 9pm: 8mg) at the end of two
weeks. Naltrexone will be taken once daily 50 mg/day with no titration schedule. The stable
dose of both medications will continue for four more weeks and medication compliance will be
evaluated through pill counts, the IVR daily monitoring, and riboflavin trace in urine
analysis. On approximately day 49 participants will come into the lab for the craving
inductions (there will be a two week window after day 49 in which participants may still be
seen if scheduling issues arise). The order of the craving inductions will be
counterbalanced, and their administration will be separated in time by 30 minutes to minimize
carry over between them. Subjective responses to the craving inductions will be obtained via
relief oriented craving items and reward oriented craving items from the Desire for Alcohol
Questionnaire. Participants will then be assisted in returning their craving levels to
baseline prior to debriefing. They will all be offered VA or community referrals to
treatment. Both prazosin and naltrexone can be safely discontinued without tapering.
prazosin and naltrexone participants will undergo two craving inductions, one oriented
towards relief craving and the other towards reward craving. Daily IVR (Interactive Voice
Recording System) data on craving and consumption and PTSD symptomatology will be collected
during the 7 days immediately following the initial assessment visit to establish a
pre-medication baseline. One hundred twenty individuals with adequate IVR compliance and
whose screening lab tests indicate it is safe for them to take the study medications will
enter the medication phase of the study within 14 days of the initial assessment initiating
prazosin/placebo as well as 50mg naltrexone/placebo treatment. Randomization will be blocked
by gender, PTSD status, and desire to abstain vs. desire to cut down. Prazosin will be
titrated to three times daily dosing (9 am: 4mg; 3pm: 4 mg; 9pm: 8mg) at the end of two
weeks. Naltrexone will be taken once daily 50 mg/day with no titration schedule. The stable
dose of both medications will continue for four more weeks and medication compliance will be
evaluated through pill counts, the IVR daily monitoring, and riboflavin trace in urine
analysis. On approximately day 49 participants will come into the lab for the craving
inductions (there will be a two week window after day 49 in which participants may still be
seen if scheduling issues arise). The order of the craving inductions will be
counterbalanced, and their administration will be separated in time by 30 minutes to minimize
carry over between them. Subjective responses to the craving inductions will be obtained via
relief oriented craving items and reward oriented craving items from the Desire for Alcohol
Questionnaire. Participants will then be assisted in returning their craving levels to
baseline prior to debriefing. They will all be offered VA or community referrals to
treatment. Both prazosin and naltrexone can be safely discontinued without tapering.
Inclusion Criteria:
- Current primary DSM-V diagnosis of alcohol use disorder
- 3+ binge drinking days last month or heavy drinking for at least 2 of the previous 4
weeks or heavy drinking at some point in the last 3 months
- At least 18 years of age
- Good general medical health (see Exclusion Criteria below)
- Capacity to provide informed consent
- English fluency and literacy
- Veteran of US military
Exclusion Criteria:
- Psychiatric/behavioral: psychiatric disorder requiring any medication other than
anti-depressants; currently taking disulfiram, acamprosate, or naltrexone or planning
to take any of these medications during the 8-week medication phase of the study;
current dependence on any other psychoactive substance other than nicotine or
cannabis; a current diagnosis of opioid abuse, use of any opioid- containing
medications or amphetamine during the previous 14 days, or UDA positive for opioids.
- Medical: significant acute or chronic medical illness; 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.
We found this trial at
1
site
Seattle, Washington 98108
Principal Investigator: Tracy Simpson, Ph.D.
Phone: 206-277-4872
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