Alcohol DrinkingPhase 1NCT02732587
Investigating the Interactions of AZD0530 With Alcohol in Social Drinkers
A Phase 1 study testing Saracatinib in people with Alcohol Drinking, run by Yale University at 1 site in United States.
Trial summary
The purpose of this alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Saracatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 23 Mar 2016
- Phase
- Phase 1
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 21-50
- Able to read English at 6th grade level or higher and to complete study evaluations
- Social drinkers consuming 1- 6 standard alcoholic drinks per week and having engaged in at least one and no more than 5 binge drinking episodes in the past year.
- BMI 19-30
Who cannot join
- Current DSM-V abuse or dependence criteria for alcohol, dependence criteria for other substances, other than nicotine.
- Positive test results at any appointments after the initial intake appointment on urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines and/or barbiturates.
- Regular use of psychoactive drugs including anxiolytics and antidepressants.
- Psychotic or otherwise severely psychiatrically disabled.
- Medical conditions that would contraindicate the consumption of alcohol.
- History of neurological trauma or disease, delirium, or hallucinations, or any significant systemic illness or unstable medical condition.
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- Women who are pregnant, nursing, or refuse to use a reliable method of birth control. Urine pregnancy tests will be completed at intake and prior to administration of alcohol.
- Subjects who report disliking spirits will be excluded because hard liquor will be provided during the alcohol administration.
- Subjects who have taken any investigational drug and/or participated in another study which involves additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol within 4 weeks immediately preceding admission to the treatment period.
- Subjects who report any daily drug use during the 30 days prior to randomization for the following: anxiolytics, beta blockers, central nervous system stimulants, hypnotics, non-therapeutic doses of neuroleptics and antidepressants, drugs with psychotropic activity or drugs which cause excessive sedation.
- Subjects who have donated blood within the past six weeks.
- Current use (within 30 days of screening) of specific psychoactive medications (e.g., typical neuroleptics, narcotic analgesics, antiparkinsonian medications, systemic corticosteroids, or medications with significant central anticholinergic activity, etc.). Current use of warfarin.
- Current use of the following medications (CYP3A4 substrates whose metabolism may be slowed by AZD0530): carbamazepine, colchicine, cyclosporine, disopyramide, fluticasone, quinidine, vinblastine, vincristine, nifedipine. Patients taking sildenafil, tadalafil, and vardenafil will be advised to stop taking these medications for the duration of the trial. Patients cannot take the following drugs which inhibit the CYP3A4 isoenzyme: cimetidine, cyclosporine, danazol, fluconazole, grapefruit juice, HIV protease inhibitors, itraconazole, ketoconazole, macrolides, miconazole, nefazodone, omeprazole, ritonavir, and verapamil.
- Neutropenia defined as absolute neutrophils count of <1,500/microliter.
- Thrombocytopenia defined as platelet count <100x103/microliter.
- Liver function tests (AST, ALT, total bilirubin) >1.5 times upper limit of normal (ULN); serum creatinine, >2 times ULN, total bilirubin>1.5 times ULN; Serum creatinine >2.0 times ULN.
- History of interstitial lung disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
CMHC, Substance Abuse Center
New Haven, Connecticut, 06519
About this study
Official title: A Phase 1 Study Investigating the Interactions of AZD0530 With Alcohol in Social Drinkers
The purpose of this alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol related responses. This is a within subjects open label study in which the investigators plan to run 8 subjects to obtain 5 completers.
Read the detailed description
The purpose of this alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol related responses. This is a within subjects open label study in which the investigators plan to run 8 subjects to obtain 5 completers.
Subjects will participate in two lab sessions, one prior to taking medication and one following 8-11 days of AZD0530. During each session, participants will receive successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl; this dose was chosen because this is close to the legal limit of intoxication and to the peak blood alcohol content (BAC) we have observed in prior research studies.Subjects will be monitored throughout the lab session and will receive a phone call two days following the 2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any remaining side effects from the medication.
Once it is determined that there is no change in the pharmacokinetics of alcohol or AZD0530, as well as no difference in behavioral or cognitive responses to alcohol in the presence of AZD0530, the investigators will begin the pilot study examining the effects of two doses of AZD0530 on behavioral measures related to alcohol self-administration following a fixed dose of alcohol in alcohol abusive or dependent heavy drinkers, and compare responses to those obtained from historical controls who were treated with placebo in Study 1. Subjects will be randomized to one of two doses of AZD0530 (50 mg/day or 125 mg/day) as a between subjects factor.
- Conditions
- Alcohol Drinking
- Being tested
- Saracatinib
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaracatinibDrug
Also called AZD0530
Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session
| Study group | Role | What they receive |
|---|---|---|
| 125 mg Saracatinib | Experimental | 125 mg Saracatinib once daily for 8-11 days Receives: Drug: Saracatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability of Study Medication.
Number of subjects - taking 125 mg of AZD0530 (saracatinib) over 8 days - in an alcohol drinking paradigm raising blood alcohol to 80 mg/dl who had any concerning changes in physiological or behavioral outcome measures.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startNov 2015
- Primary completion15 Mar 2016
- Study completion23 Mar 2016
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 Alcohol DrinkingStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Suchitra Krishnan-Sarin, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732587
- Sponsor's protocol ID
- 0602001068-2
- Other IDs
- P50AA012870
- Status last verified
- Jan 2020
- First submitted
- 9 Nov 2015
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Investigating the Interactions of AZD0530 With Alcohol in Social Drinkers
- ClinicalTrials.gov ID
- NCT02732587
- Acronym / sponsor ID
- 0602001068-2
- Conditions
- Alcohol Drinking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2015 (actual)
- Primary completion
- 15 Mar 2016 (actual)
- Study completion
- 23 Mar 2016 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Posted 14 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol related responses. This is a within subjects open label study in which the investigators plan to run 8 subjects to obtain 5 completers.
Detailed description
The purpose of this alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol related responses. This is a within subjects open label study in which the investigators plan to run 8 subjects to obtain 5 completers.
Subjects will participate in two lab sessions, one prior to taking medication and one following 8-11 days of AZD0530. During each session, participants will receive successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl; this dose was chosen because this is close to the legal limit of intoxication and to the peak blood alcohol content (BAC) we have observed in prior research studies.Subjects will be monitored throughout the lab session and will receive a phone call two days following the 2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any remaining side effects from the medication.
Once it is determined that there is no change in the pharmacokinetics of alcohol or AZD0530, as well as no difference in behavioral or cognitive responses to alcohol in the presence of AZD0530, the investigators will begin the pilot study examining the effects of two doses of AZD0530 on behavioral measures related to alcohol self-administration following a fixed dose of alcohol in alcohol abusive or dependent heavy drinkers, and compare responses to those obtained from historical controls who were treated with placebo in Study 1. Subjects will be randomized to one of two doses of AZD0530 (50 mg/day or 125 mg/day) as a between subjects factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 125 mg Saracatinib | Experimental | Drug: Saracatinib125 mg Saracatinib once daily for 8-11 days |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 21-50
- Able to read English at 6th grade level or higher and to complete study evaluations
- Social drinkers consuming 1- 6 standard alcoholic drinks per week and having engaged in at least one and no more than 5 binge drinking episodes in the past year.
- BMI 19-30
Key exclusion criteria (17 listed)
- Current DSM-V abuse or dependence criteria for alcohol, dependence criteria for other substances, other than nicotine.
- Positive test results at any appointments after the initial intake appointment on urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines and/or barbiturates.
- Regular use of psychoactive drugs including anxiolytics and antidepressants.
- Psychotic or otherwise severely psychiatrically disabled.
- Medical conditions that would contraindicate the consumption of alcohol.
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 |
|---|---|---|
| SaracatinibAlso: AZD0530Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session | Drug | 125 mg Saracatinib |
Primary outcome
Safety/Tolerability of Study Medication.
Time frame: 8 days
Number of subjects - taking 125 mg of AZD0530 (saracatinib) over 8 days - in an alcohol drinking paradigm raising blood alcohol to 80 mg/dl who had any concerning changes in physiological or behavioral outcome measures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saracatinib in people with Alcohol Drinking, 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 4 inclusion and 17 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 Jan 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2020). 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?
Safety/Tolerability of Study Medication. (time frame: 8 days). 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 14 Jan 2020.