Alcohol DrinkingPhase 4NCT04742348
Research on Translational Outcomes of Alcohol (Project RETRO)
A Phase 4 study testing Carbidopa Levodopa in people with Alcohol Drinking, run by University of Washington.
Trial summary
The primary aim of the current study is to assess the effect of a single dose of carbidopa-levodopa on ad libitum alcohol consumption and alcohol craving in young adults with a history of binge drinking. Read more about this study
- Who is it for?
- Ages 21 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Carbidopa Levodopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Aug 2023
- Phase
- Phase 4
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrolled in 2- or 4-year college program
- Currently living in the Seattle Metropolitan area
- Have at least two or more episodes of heavy episodic drinking (4/5 or more drinks in a 2 hours for women/men) in the past 30 days.
Who cannot join
- past-month severe alcohol or other substance use disorders,
- mood or anxiety disorder
- suicidal ideation
- risk of psychotic disorders
- excessive alcohol use reaching a Blood Alcohol Level greater than .30%
- history of serious medical conditions, regular use of prescription psychotropic or pain medication
Show all 14Show fewer
- history of negative reactions to alcohol
- history of treatment for alcohol use disorder
- pregnancy or nursing.
- use of non-selective monoamine oxidase inhibitors in the past 2 weeks.
- narrow-angle glaucoma
- undiagnosed skin lesions,
- have a history of melanoma, cardiac issues or peptic ulcer.
- Currently taking or prescribed any form of levodopa or D2 agonists, D2 antagonists, isoniazid, methylphenidate, bupropion, Viagra, or phosphodiesterase inhibitors.
About this study
The primary aim of the current study is to assess the effect of a single dose of carbidopa-levodopa on ad libitum alcohol consumption and alcohol craving in young adults with a history of binge drinking.
Read the detailed description
This is a small (N = 42) 2-arm, double-blind, randomized controlled pilot study to assess the effect of a single dose of immediate release carbidopa-levodopa (50mg/500mg) to acutely reduce alcohol consumption and craving in college students with a history of heavy episodic drinking. Participants will be between 21-24 years old from 2- and 4- year colleges in the Seattle Metropolitan area. Interested students will contact the study line and provide verbal consent to be sent a link to an online screening survey. Eligible participants will be scheduled to come in for the ad libitum alcohol administration. Participants will receive either the carbidopa-levodopa or a placebo and complete the alcohol administration protocol.
- Conditions
- Alcohol Drinking
- Being tested
- Carbidopa Levodopa, Placebo
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbidopa LevodopaDrug
Participants who are randomized to active drug group will receive 1 dose of immediate release carbidopa-levodopa (50mg/500mg) .
PlaceboDrug
Participants who are randomized to placebo group will be provided with similar looking tablet(s) as the active drug.
| Study group | Role | What they receive |
|---|---|---|
| Control, Placebo | Placebo comparator | Similar looking tablet(s) to active drug will be administered in a single dose to those who are randomly assigned to this group. Receives: Drug: Placebo |
| Active Drug, Carbidopa + Levodopa | Experimental | Single dose of immediate release carbidopa-levodopa (50mg/500mg). Receives: Drug: Carbidopa Levodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption
Number of alcoholic drinks consumed
Measured: 1 hour
Alcohol Craving
Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn \& Staehler (1995)
Measured: 30 minutes in to alcohol administration
Secondary outcomes (1)
Alcohol craving
Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn \& Staehler (1995)
Measured: At the end of alcohol administration. Alcohol administration is 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study startFeb 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: COVID-19 and expiration of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittney Hultgren, University of Washington
- Investigators
- Brittney Hultgren, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742348
- Sponsor's protocol ID
- STUDY00009051
- Status last verified
- Feb 2023
- First submitted
- 9 Nov 2020
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Translational Outcomes of Alcohol (Project RETRO)
- ClinicalTrials.gov ID
- NCT04742348
- Acronym / sponsor ID
- STUDY00009051
- Conditions
- Alcohol Drinking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 and expiration of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Feb 2021 (actual)
- 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.
The primary aim of the current study is to assess the effect of a single dose of carbidopa-levodopa on ad libitum alcohol consumption and alcohol craving in young adults with a history of binge drinking.
Detailed description
This is a small (N = 42) 2-arm, double-blind, randomized controlled pilot study to assess the effect of a single dose of immediate release carbidopa-levodopa (50mg/500mg) to acutely reduce alcohol consumption and craving in college students with a history of heavy episodic drinking. Participants will be between 21-24 years old from 2- and 4- year colleges in the Seattle Metropolitan area. Interested students will contact the study line and provide verbal consent to be sent a link to an online screening survey. Eligible participants will be scheduled to come in for the ad libitum alcohol administration. Participants will receive either the carbidopa-levodopa or a placebo and complete the alcohol administration protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control, Placebo | Placebo comparator | Drug: PlaceboSimilar looking tablet(s) to active drug will be administered in a single dose to those who are randomly assigned to this group. |
| Active Drug, Carbidopa + Levodopa | Experimental | Drug: Carbidopa LevodopaSingle dose of immediate release carbidopa-levodopa (50mg/500mg). |
Who may qualify
- Ages
- 21 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Enrolled in 2- or 4-year college program
- Currently living in the Seattle Metropolitan area
- Have at least two or more episodes of heavy episodic drinking (4/5 or more drinks in a 2 hours for women/men) in the past 30 days.
Key exclusion criteria (14 listed)
- past-month severe alcohol or other substance use disorders,
- mood or anxiety disorder
- suicidal ideation
- risk of psychotic disorders
- excessive alcohol use reaching a Blood Alcohol Level greater than .30%
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 |
|---|---|---|
| Carbidopa LevodopaParticipants who are randomized to active drug group will receive 1 dose of immediate release carbidopa-levodopa (50mg/500mg) . | Drug | Active Drug, Carbidopa + Levodopa |
| PlaceboParticipants who are randomized to placebo group will be provided with similar looking tablet(s) as the active drug. | Drug | Control, Placebo |
Primary outcome
Alcohol Consumption
Time frame: 1 hour
Number of alcoholic drinks consumed
Alcohol Craving
Time frame: 30 minutes in to alcohol administration
Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn \& Staehler (1995)
1 secondary outcome
Alcohol craving
Time frame: At the end of alcohol administration. Alcohol administration is 1 hour.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
Related trials for Alcohol Drinking
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
Brittney Hultgren, PhD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carbidopa Levodopa in people with Alcohol Drinking, run by University of Washington.
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 14 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: withdrawn, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Alcohol Consumption (time frame: 1 hour). 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 Feb 2023.