NCT00004554
Who may be able to join
Who might be able to join this trial:
- You are a man or woman between 18 and 75 years old who is seen as an outpatient (not staying overnight in a hospital).
- You have been diagnosed with a major depressive episode (either on its own or related to alcohol use) based on standard medical criteria.
- You have been diagnosed with alcohol dependence.
- You score 10 or higher on a standard depression rating scale at the time you enter the trial, with a specific item on that scale also showing a certain level of depressive symptoms (confirm with trial site).
- In the month before seeking treatment, you drank alcohol on at least 40% of days, or had more than 40 standard drinks in that month (roughly 10 or more drinks per week on average).
- You have safely completed a medical alcohol detox programme and have not had any alcohol for at least 4 days in a row, OR if detox was not needed, you have still been alcohol-free for at least 4 consecutive days before starting the study medication.
- If you are a woman who could become pregnant, you must have a negative pregnancy test, not be planning to become pregnant in the next 6 months, and be using an effective form of contraception.
Who may not be able to join:
- You have used opiates (such as heroin or certain painkillers) in the past 30 days, or have previously had treatment for opiate dependence.
- In the past year, you have been dependent on any substance other than alcohol or nicotine, or you test positive for certain drugs (other than cannabis/THC) at your first visit.
- You have a current or past diagnosis of schizophrenia, any psychotic disorder, or bipolar disorder.
- You have a significant or unstable medical condition affecting your blood, lungs, hormones, heart, kidneys, or digestive system (if the condition has been stable for over a year and is judged unlikely to affect your participation, you may still be eligible — confirm with trial site).
- Your liver function blood test results are more than 3.5 times above the normal range, or your bilirubin levels are abnormally high.
- You currently need to take any psychiatric or mood-related medications (with a few limited exceptions such as a sleep aid or nicotine replacement therapy — confirm with trial site).
- You have taken the antidepressant fluoxetine (Prozac) within the last 6 weeks.
- You have taken a type of antidepressant called an MAOI within the last 2 weeks.
- You have taken any other antidepressant or psychiatric medication within the last 7 days.
- You are currently taking part in another clinical drug trial, or have done so within the past month.
- You are unable to read or write in English.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial details
Where this trial is recruiting
Primary endpoints
Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD).
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.