AlcoholismNCT00240227
Prazosin for ETOH or Cocaine Craving
A study testing Prazosin in people with Alcoholism and Cocaine Dependence, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This double-blind placebo controlled crossover pilot trial will test the hypothesis that prazosin, an alpha-1 adrenergic receptor antagonist, reduces craving for their drug of choice in cocaine-dependent and alcohol-dependent veterans. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholism, Cocaine Dependence
- What is being tested?
- Prazosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Current DSM-IV diagnosis of alcohol dependence or cocaine dependence with no use in last 30 days
- Capacity to provide informed consent
- Actively enrolled in chemical dependency treatment at VA Puget Sound English fluency
Who cannot join
- Evidence of significant abuse of opiates, PCP, sedatives or anxiolytics
- Suicidal ideation
- DSM IV diagnosis of bipolar mood disorder, schizophrenia or schizoaffective disorder
- Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic < 110), or orthostatic hypotension (systolic drop > 20mmHg after two minutes standing or any drop with dizziness), insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, M ni re's disease, benign positional vertigo, narcolepsy
- Concomitant use of alpha-1 antagonists History of prazosin-sensitivity Women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the investigator to be effective
- Non-compliance with outpatient chemical dependency treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98109
About this study
Official title: The Role of the Alpha 1-adrenergic Antagonist, Prazosin, in the Reduction of Craving and Relapse in Alcohol and Cocaine-dependent Individuals: a Double-blind, Randomized, Controlled Clinical Trial
This double-blind placebo controlled crossover pilot trial will test the hypothesis that prazosin, an alpha-1 adrenergic receptor antagonist, reduces craving for their drug of choice in cocaine-dependent and alcohol-dependent veterans. Both the study medication period and the placebo period are each 4 weeks in duration.
Read the detailed description
- Objective of the project: To evaluate the efficacy of prazosin on the reduction of craving in alcohol and cocaine dependent individuals. The investigators hypothesize that prazosin will be more effective than placebo in the reduction of craving that is stimulated by exposure to visual cues or to intolerance to stress in individuals dependent on cocaine and in individuals dependent on alcohol. Specifically, the investigators hypothesize that in this laboratory study:
- Subjects in the prazosin condition will report a reduction in craving induced in the laboratory by exposure to visual cues compared to subjects in the placebo condition.
- Subjects in the prazosin condition will show less reaction of the noradrenergic system when craving is induced in the laboratory by exposure to visual cues compared to subjects in the placebo condition.
- Subjects will be less likely to relapse to their drug of choice while they are in the prazosin condition compared to when they are in the placebo condition. Most individuals who are able to achieve sobriety in chemical dependency treatment eventually relapse. Until the investigators can prevent the cravings for drugs, which usually precedes relapse, it is unlikely that the investigators will have more effective treatment for drug addiction. Our final hypothesis is that the alpha-1, adrenergic antagonist, prazosin, will prove to be an effective pharmacological agent for treatment of drug dependency.
- Research plan study design: The proposed study will be a double-blind, placebo-controlled, crossover study of prazosin in subjects who are either dependent on alcohol or on cocaine, and who have been able to achieve one month of sobriety while in intensive outpatient treatment. The double-blind, crossover protocol will last 8 weeks and will include 32 subjects; 16 of whom are alcohol-dependent, and 16 of whom are cocaine-dependent. The focus of this first study will be on subjective and physiological measures of craving that will be induced in a controlled setting by exposure to visual cues.
- Methodology Setting: This study will occur in room 6A-107 in Building 1 at the Veterans Administration Puget Sound Health Care System in Seattle. This is a soundproof room specifically designed and constructed for studies of this type. Participants: 16 alcohol-dependent adults and 16 cocaine-dependent adults presenting for chemical dependency treatment at the VA Puget Sound Health Care System (VAPSHCS) Addiction Treatment Center. Study Procedures: Once potential subjects have provided their consent to participate in the study, they will undergo a 2 hour baseline assessment that consists of some pencil and paper questionnaires, providing a medical and psychiatric history, and a physical exam. They will provide blood for some basic screening labs to insure they are healthy enough to proceed with the study, and have their baseline vital signs measured. Veterans who are screened for the study will then be enrolled once their lab results and the screening process have determined that they do not meet any medical exclusion criteria. At that point, participants will be randomized to either the study medication or placebo. During the course of the study, participants continue with their outpatient chemical dependency treatment through the Addiction Treatment Center at the VA Puget Sound. During the eight weeks of the study, participants will have weekly orthostatic vital sign and adverse events monitoring by the study nurse or physician. All serious or unexpected adverse events will be reported to the FDA and UW Human Subjects Committee in accordance with requirements. Participants will also provide self-reports of drug or alcohol use and urine drug analysis specimens at these weekly visits. At the end of week 4, each participant will be tested in a 1 hour craving session in room 6A-107 at VA Puget Sound. Subjects will have their heart rate and skin conductance response continuously measured, and have their blood pressure measured every 5 minutes. They will be shown 5 1-minute films, 3 of which are designed to be neutral and 2 of which are designed to provoke craving for their drug of choice. They will be asked to complete a subjective scale of craving prior to each video and after the last video. Participants will not be permitted to leave the craving lab after the last film, until they feel that they have subjectively returned to a level of normal physiological arousal and are no longer experiencing any craving.
- Findings: No findings to date.
- Conditions
- Alcoholism, Cocaine Dependence
- Being tested
- Prazosin, placebo
- Keywords
- Alcoholism, Cocaine Dependence, Prazosin, Substance use disorders
- Medical subject headings
- Alcoholism, Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrazosinDrug
Also called Mini Press
FDA approved medication for hypertension
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Other | Placebo no active medication Receives: Drug: placebo |
| prazosin | Active comparator | Prazosin flexible dose titration up to 12 mg per day. Receives: Drug: Prazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
Measured: During lab session
Secondary outcomes (5)
Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
Measured: During lab session
Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
Measured: During lab session
Change in Subjective Experience of Craving in Response to Provocative Visual Cues Designed to Elicit Craving, as Measured by the Within Session Rating for Cocaine/Alcohol Craving
Measured: During lab session
Change in Self-reports of Substance Use Between Study Medication and Placebo Periods
Measured: 4 weeks
Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startApr 2004
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Experimental procedure did not induce sufficient craving to determine any possible effect of medication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Andrew J. Saxon, MD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240227
- Sponsor's protocol ID
- REAP 05-0020
- Status last verified
- Aug 2018
- First submitted
- 13 Oct 2005
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Alpha 1-adrenergic Antagonist, Prazosin, in the Reduction of Craving and Relapse in Alcohol and Cocaine-dependent Individuals: a Double-blind, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00240227
- Acronym / sponsor ID
- REAP 05-0020
- Conditions
- Alcoholism, Cocaine Dependence
- Keywords
- Alcoholism, Cocaine Dependence, Prazosin, Substance use disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Experimental procedure did not induce sufficient craving to determine any possible effect of medication.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind placebo controlled crossover pilot trial will test the hypothesis that prazosin, an alpha-1 adrenergic receptor antagonist, reduces craving for their drug of choice in cocaine-dependent and alcohol-dependent veterans. Both the study medication period and the placebo period are each 4 weeks in duration.
Detailed description
- Objective of the project: To evaluate the efficacy of prazosin on the reduction of craving in alcohol and cocaine dependent individuals. The investigators hypothesize that prazosin will be more effective than placebo in the reduction of craving that is stimulated by exposure to visual cues or to intolerance to stress in individuals dependent on cocaine and in individuals dependent on alcohol. Specifically, the investigators hypothesize that in this laboratory study:
- Subjects in the prazosin condition will report a reduction in craving induced in the laboratory by exposure to visual cues compared to subjects in the placebo condition.
- Subjects in the prazosin condition will show less reaction of the noradrenergic system when craving is induced in the laboratory by exposure to visual cues compared to subjects in the placebo condition.
- Subjects will be less likely to relapse to their drug of choice while they are in the prazosin condition compared to when they are in the placebo condition. Most individuals who are able to achieve sobriety in chemical dependency treatment eventually relapse. Until the investigators can prevent the cravings for drugs, which usually precedes relapse, it is unlikely that the investigators will have more effective treatment for drug addiction. Our final hypothesis is that the alpha-1, adrenergic antagonist, prazosin, will prove to be an effective pharmacological agent for treatment of drug dependency.
- Research plan study design: The proposed study will be a double-blind, placebo-controlled, crossover study of prazosin in subjects who are either dependent on alcohol or on cocaine, and who have been able to achieve one month of sobriety while in intensive outpatient treatment. The double-blind, crossover protocol will last 8 weeks and will include 32 subjects; 16 of whom are alcohol-dependent, and 16 of whom are cocaine-dependent. The focus of this first study will be on subjective and physiological measures of craving that will be induced in a controlled setting by exposure to visual cues.
- Methodology Setting: This study will occur in room 6A-107 in Building 1 at the Veterans Administration Puget Sound Health Care System in Seattle. This is a soundproof room specifically designed and constructed for studies of this type. Participants: 16 alcohol-dependent adults and 16 cocaine-dependent adults presenting for chemical dependency treatment at the VA Puget Sound Health Care System (VAPSHCS) Addiction Treatment Center. Study Procedures: Once potential subjects have provided their consent to participate in the study, they will undergo a 2 hour baseline assessment that consists of some pencil and paper questionnaires, providing a medical and psychiatric history, and a physical exam. They will provide blood for some basic screening labs to insure they are healthy enough to proceed with the study, and have their baseline vital signs measured. Veterans who are screened for the study will then be enrolled once their lab results and the screening process have determined that they do not meet any medical exclusion criteria. At that point, participants will be randomized to either the study medication or placebo. During the course of the study, participants continue with their outpatient chemical dependency treatment through the Addiction Treatment Center at the VA Puget Sound. During the eight weeks of the study, participants will have weekly orthostatic vital sign and adverse events monitoring by the study nurse or physician. All serious or unexpected adverse events will be reported to the FDA and UW Human Subjects Committee in accordance with requirements. Participants will also provide self-reports of drug or alcohol use and urine drug analysis specimens at these weekly visits. At the end of week 4, each participant will be tested in a 1 hour craving session in room 6A-107 at VA Puget Sound. Subjects will have their heart rate and skin conductance response continuously measured, and have their blood pressure measured every 5 minutes. They will be shown 5 1-minute films, 3 of which are designed to be neutral and 2 of which are designed to provoke craving for their drug of choice. They will be asked to complete a subjective scale of craving prior to each video and after the last video. Participants will not be permitted to leave the craving lab after the last film, until they feel that they have subjectively returned to a level of normal physiological arousal and are no longer experiencing any craving.
- Findings: No findings to date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Other | Drug: placeboPlacebo no active medication |
| prazosin | Active comparator | Drug: PrazosinPrazosin flexible dose titration up to 12 mg per day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years
- Current DSM-IV diagnosis of alcohol dependence or cocaine dependence with no use in last 30 days
- Capacity to provide informed consent
- Actively enrolled in chemical dependency treatment at VA Puget Sound English fluency
Key exclusion criteria (6 listed)
- Evidence of significant abuse of opiates, PCP, sedatives or anxiolytics
- Suicidal ideation
- DSM IV diagnosis of bipolar mood disorder, schizophrenia or schizoaffective disorder
- Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic < 110), or orthostatic hypotension (systolic drop > 20mmHg after two minutes standing or any drop with dizziness), insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, M ni re's disease, benign positional vertigo, narcolepsy
- Concomitant use of alpha-1 antagonists History of prazosin-sensitivity Women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the investigator to be effective
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 |
|---|---|---|
| PrazosinAlso: Mini PressFDA approved medication for hypertension | Drug | prazosin |
| placebo | Drug | Placebo |
Primary outcome
Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
Time frame: During lab session
5 secondary outcomes
Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
Time frame: During lab session
Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group
Time frame: During lab session
Change in Subjective Experience of Craving in Response to Provocative Visual Cues Designed to Elicit Craving, as Measured by the Within Session Rating for Cocaine/Alcohol Craving
Time frame: During lab session
Change in Self-reports of Substance Use Between Study Medication and Placebo Periods
Time frame: 4 weeks
Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew J. Saxon, MD principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prazosin in people with Alcoholism and Cocaine Dependence, run by US Department of Veterans Affairs 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 31 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group (time frame: During lab session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2018.