CompletedPhase 2

Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana

49 participantsStarted 2006-12

Plain-language summary

The purpose of this study is to determine if the subjective effects of marijuana will be decreased by low-doses (\< 25 mg) of naltrexone and increased by high-doses (\> 50 mg) of naltrexone.

Who can participate

Age range

21 Years – 45 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: * Current marijuana use * Able to perform study procedures * 21-45 years of age * Women practicing an effective form of birth control Exclusion Criteria: * Current, repeated illicit drug use (other than marijuana) * Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory hepatitis, clinically significant laboratory abnormalities, tests, 12-lead ECG, Mantoux test LFTs \> 3x upper limit of normal) * History of heart disease * Request for drug treatment * Current parole or probation * Pregnancy or current lactation * Recent history of significant violent behavior * Previous adverse reaction to naltrexone * Major current Axis I psychopathology Psychiatric interview (e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia) * Current use of any prescription or over-the-counter medication

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

Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose.

Timeframe: Baseline compared to 6 week timepoint

Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose

Timeframe: Baseline compared to 6 week timepoint

Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.

Timeframe: Baseline compared to 6 week timepoint

Trial details

NCT IDNCT00403117

SponsorNew York State Psychiatric Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-05

Results submitted2017-08-07

View on ClinicalTrials.gov More Marijuana Use trials

Who can participate

Age range

21 Years – 45 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.

What they're measuring

Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose.

Timeframe: Baseline compared to 6 week timepoint

Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose

Timeframe: Baseline compared to 6 week timepoint

Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.

Timeframe: Baseline compared to 6 week timepoint