Alcohol DrinkingPhase 2NCT02955186
Saracatinib and Alcohol Drinking
A Phase 2 study testing Saracatinib in people with Alcohol Drinking, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of the study medication, saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. 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?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2017to 7 Jun 2019
- Phase
- Phase 2
- 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
- Regular alcohol drinker
Who cannot join
- Individuals who are seeking alcohol treatment
- Medical conditions that would contraindicate the use of saracatinib
- Regular use of other substances
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: Fyn Kinase Inhibitors and Alcohol Drinking
The purpose of this study is to evaluate the effects of the study medication, saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. The investigators hypothesize that saracatinib will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.
- Conditions
- Alcohol Drinking
- Being tested
- Saracatinib, Placebos
- 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
Saracatinib 125 mg once per day for 8 days
PlacebosDrug
Placebo once per day for 8 days
| Study group | Role | What they receive |
|---|---|---|
| 125 mg saracatinib | Experimental | Participants will take 125 mg of saracatinib daily for 8 days. Receives: Drug: Saracatinib |
| Placebo | Placebo comparator | Participants will take placebo daily for 8 days. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)
Change in the number of standard drinks consumed at the drinking session (ADP 2) after taking study medication minus the number of standard drinks consumed at baseline (ADP 1).
Measured: Baseline and Day 8
Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS
Craving for alcohol based on Yale Craving Scale (YCS), scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.
Measured: Baseline and Day 7
Secondary outcomes (2)
Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES)
Biphasic Alcohol Effects Scale (BAES) scores will be used to assess stimulation. The scale ranges from 0-70, with a higher score indicating more sedated.
Measured: Day 8 Adlib
Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES)
Biphasic Alcohol Effects Scale (BAES) scores will be used to assess sedation. The scale ranges from 0-70, with a higher score indicating more sedated.
Measured: Day 8 Adlib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start9 May 2017
- Primary completion24 Apr 2019
- Study completion7 Jun 2019
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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 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
- NCT02955186
- Sponsor's protocol ID
- 1601017043
- Other IDs
- 2P50AA012870-16
- Status last verified
- Oct 2020
- First submitted
- 1 Nov 2016
- Last updated
- 13 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fyn Kinase Inhibitors and Alcohol Drinking
- ClinicalTrials.gov ID
- NCT02955186
- Acronym / sponsor ID
- 1601017043
- Conditions
- Alcohol Drinking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 9 May 2017 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Posted 13 Nov 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 study is to evaluate the effects of the study medication, saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. The investigators hypothesize that saracatinib will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 125 mg saracatinib | Experimental | Drug: SaracatinibParticipants will take 125 mg of saracatinib daily for 8 days. |
| Placebo | Placebo comparator | Drug: PlacebosParticipants will take placebo daily for 8 days. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 21-50
- Able to read English at 6th grade level or higher and to complete study evaluations
- Regular alcohol drinker
Key exclusion criteria (3 listed)
- Individuals who are seeking alcohol treatment
- Medical conditions that would contraindicate the use of saracatinib
- Regular use of other substances
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: AZD0530Saracatinib 125 mg once per day for 8 days | Drug | 125 mg saracatinib |
| PlacebosPlacebo once per day for 8 days | Drug | Placebo |
Primary outcome
Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)
Time frame: Baseline and Day 8
Change in the number of standard drinks consumed at the drinking session (ADP 2) after taking study medication minus the number of standard drinks consumed at baseline (ADP 1).
Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS
Time frame: Baseline and Day 7
Craving for alcohol based on Yale Craving Scale (YCS), scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.
2 secondary outcomes
Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES)
Time frame: Day 8 Adlib
Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES)
Time frame: Day 8 Adlib
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 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 2 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 3 inclusion and 3 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 13 Nov 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Nov 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?
Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline) (time frame: Baseline and Day 8). The study lists 2 primary outcomes in all. 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 13 Nov 2020.