CompletedNot Applicable

Examination of Zinc, S-adenosylmethionine, and Combination Therapy Versus Placebo in Alcoholics

United States113 participantsStarted 2013-05-01

Plain-language summary

This is a randomized, placebo controlled trial of dietary zinc and S-adenosylmethionine (SAMe) in otherwise healthy alcoholic US Veterans. The primary goal is to determine if either dietary zinc or S-adenosylmethionine (SAMe) can augment lung immune defenses in alcoholics and thereby decrease the risk of lung injury and infection.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-60 years * Active alcohol use disorder Exclusion Criteria: * Any active and uncontrolled medical problem(s) * Known zinc deficiency * Primary substance of abuse something other than alcohol * Current abnormal chest x-ray * HIV-positive * Any disorder of blood coagulation * Currently on medical treatment with anti-coagulants, including: * warfarin * heparin * direct thrombin inhibitors * anti-platelet agents (other than Aspirin) * Daily use of vitamins or other nutritional supplements (unless taking as treatment for alcohol use disorder) * Renal impairment (GFR \< 60) * Active bipolar disorder * Active Parkinson's disease * Current pregnancy * Contraindication to treatment with zinc or S-adenosylmethionine * Inability to give informed consent (i.e., limited cognitive capacity) * Non-English speaking

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Endpoint

Timeframe: Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)

Trial details

NCT IDNCT01899521

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2017-07-31

Results submitted2023-01-09

View on ClinicalTrials.gov More Alcoholism trials