Marijuana UsePhase 2NCT00403117
Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana
A Phase 2 study testing Naltrexone 12 Mg+ Active Marijuana (3.27% THC), Naltrexone 25 Mg + Active Marijuana (3.27% THC) and Naltrexone 50 Mg+ Active Marijuana (3.27% THC) in people with Marijuana Use, run by New York State Psychiatric Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Use
- What is being tested?
- Naltrexone 12 Mg+ Active Marijuana (3.27% THC), Naltrexone 25 Mg + Active Marijuana (3.27% THC) and Naltrexone 50 Mg+ Active Marijuana (3.27% THC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Aug 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current marijuana use
- Able to perform study procedures
- 21-45 years of age
- Women practicing an effective form of birth control
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
Official title: Opioid Antagonism Enhances Marijuana's Effects in Heavy Marijuana Smokers
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.
Read the detailed description
Laboratory animal studies demonstrate that endogenous cannabinoids and opioids are closely inter-related. We have completed a series of studies in marijuana smokers showing that a clinically-utilized dose of naltrexone (50 mg) enhanced the reinforcing and subjective effects of orally-administered tetrahydrocannabinol (THC), while a low naltrexone dose (12 mg) blunted the effects of THC. A better understanding of the effects of a range of naltrexone doses in combination with smoked marijuana has important implications for the following reasons: (1) Alcohol- and opioid-dependent patients receive high doses of naltrexone (50-150 mg), which may increase the abuse liability of marijuana, (2) Low-dose naltrexone blunts THC's intoxicating effects, suggesting potential utility as a treatment medication for marijuana dependence. This study will determine if naltrexone (0, 12, 25, 50, 100 mg) administration 45 min prior to marijuana administration (0, 3.27% THC) alters marijuana's subjective, cognitive or physiological effects. Marijuana smokers will spend approximately 5h/day for a total of 10 days in the outpatient laboratory. Participants will visit the outpatient laboratory 2-3 times per week, with a minimum 48-hr interval between sessions to allow for naltrexone clearance. These data will provide important information regarding the clinical use of naltrexone.
- Conditions
- Marijuana Use
- Being tested
- Placebo + Inactive Marijuana (0% THC), Placebo + Active Marijuana (3.27% THC), Naltrexone 12 Mg+ Active Marijuana (3.27% THC), Naltrexone 25 Mg + Active Marijuana (3.27% THC), Naltrexone 50 Mg+ Active Marijuana (3.27% THC)
- Keywords
- Naltrexone, Smoked Marijuana
- Medical subject headings
- Marijuana Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo + Inactive Marijuana (0% THC)Drug
Also called treatment type 1
One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
Placebo + Active Marijuana (3.27% THC)Drug
Also called treatment type 2
One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before administration of a marijuana cigarette containing 3.27% THC (ca. 800 mg) provided by the National Institute on Drug Abuse.
Naltrexone 12 Mg+ Active Marijuana (3.27% THC)Drug
Also called Treatment type 3
One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration.
Naltrexone 25 Mg + Active Marijuana (3.27% THC)Drug
Also called treatment type 4
One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration.
Naltrexone 50 Mg+ Active Marijuana (3.27% THC)Drug
Also called treatment type 5
One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
Naltrexone 100 Mg+ Active Marijuana (3.27% THC)Drug
Also called treatment type 6
One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
Naltrexone 12 Mg + Inactive Marijuana (0% THC)Drug
Also called treatment type 7
One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
Naltrexone 25 Mg + Inactive Marijuana (0% THC)Drug
Also called treatment type 8
One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
Naltrexone 50 Mg + Inactive Marijuana (0% THC)Drug
Also called treatment type 9
One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
Naltrexone 100 Mg + Inactive Marijuana (0% THC)Drug
Also called treatment type 10
One capsule containing 100mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
| Study group | Role | What they receive |
|---|---|---|
| Placebo, Marijuana (0% THC) | Placebo comparator | During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. Receives: Drug: Placebo + Inactive Marijuana (0% THC) |
| Placebo, Marijuana (3.27% THC) | Experimental | During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. Receives: Drug: Placebo + Active Marijuana (3.27% THC) |
| Naltrexone (12mg), Marijuana (0% THC) | Experimental | During each session, one capsule containing naltrexone (12 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. Receives: Drug: Naltrexone 12 Mg + Inactive Marijuana (0% THC) |
| Naltrexone (12mg), Marijuana (3.27% THC) | Experimental | During each session, one capsule containing naltrexone (12 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. Receives: Drug: Naltrexone 12 Mg+ Active Marijuana (3.27% THC) |
| Naltrexone (25mg), Marijuana (0% THC) | Experimental | During each session, one capsule containing naltrexone (25 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. Receives: Drug: Naltrexone 25 Mg + Inactive Marijuana (0% THC) |
| Naltrexone (25mg), Marijuana (3.27% THC) | Experimental | During each session, one capsule containing naltrexone (25 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. Receives: Drug: Naltrexone 25 Mg + Active Marijuana (3.27% THC) |
| Naltrexone (50mg), Marijuana (0% THC) | Experimental | During each session, one capsule containing naltrexone (50 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. Receives: Drug: Naltrexone 50 Mg + Inactive Marijuana (0% THC) |
| Naltrexone (50mg), Marijuana (3.27% THC) | Experimental | During each session, one capsule containing naltrexone (50 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. Receives: Drug: Naltrexone 50 Mg+ Active Marijuana (3.27% THC) |
| Naltrexone (100mg), Marijuana (0% THC) | Experimental | During each session, one capsule containing naltrexone (100 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. Receives: Drug: Naltrexone 100 Mg + Inactive Marijuana (0% THC) |
| Naltrexone (100mg), Marijuana (3.27% THC) | Experimental | During each session, one capsule containing naltrexone (100 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. Receives: Drug: Naltrexone 100 Mg+ Active Marijuana (3.27% THC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose.
All subjective effects were measured using visual analog scales (VAS), a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to rate their subjective experiences on the line according to how they felt at that particular moment. Subjective assessments included measures of perceived marijuana strength, marijuana "high", "good effects" of marijuana, and how much marijuana was "liked".
Marijuana's effects were determined by comparing the active and inactive marijuana conditions when paired with the placebo naltrexone condition (one comparison). Naltrexone's intrinsic effects were assessed by comparing placebo and each active dose of naltrexone (12, 25, 50, and 100 mg) under the inactive marijuana condition (four comparisons). Finally, the active marijuana- placebo naltrexone condition was compared to the active marijuana-active naltrexone conditions (four comparisons)
Measured: Baseline compared to 6 week timepoint
Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose
Change in Digit Symbol Substitution Test (DSST) scores. Increasing scores indicate improvement, on a scale of 0-90.
The task batteries included total correct attempts on a 3-min DSST.
Measured: Baseline compared to 6 week timepoint
Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.
Change in mean heart rate as a function of marijuana and naltrexone dose
Measured: Baseline compared to 6 week timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionMay 2008
- Study completionAug 2010
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 Marijuana UseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Margaret Haney, Ph.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403117
- Sponsor's protocol ID
- IRB# 5350
- Other IDs
- DA09236
- Status last verified
- Feb 2018
- First submitted
- 21 Nov 2006
- Last updated
- 15 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Antagonism Enhances Marijuana's Effects in Heavy Marijuana Smokers
- ClinicalTrials.gov ID
- NCT00403117
- Acronym / sponsor ID
- IRB# 5350
- Conditions
- Marijuana Use
- Keywords
- Naltrexone, Smoked Marijuana
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Research Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Posted 19 Dec 2017
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 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.
Detailed description
Laboratory animal studies demonstrate that endogenous cannabinoids and opioids are closely inter-related. We have completed a series of studies in marijuana smokers showing that a clinically-utilized dose of naltrexone (50 mg) enhanced the reinforcing and subjective effects of orally-administered tetrahydrocannabinol (THC), while a low naltrexone dose (12 mg) blunted the effects of THC. A better understanding of the effects of a range of naltrexone doses in combination with smoked marijuana has important implications for the following reasons: (1) Alcohol- and opioid-dependent patients receive high doses of naltrexone (50-150 mg), which may increase the abuse liability of marijuana, (2) Low-dose naltrexone blunts THC's intoxicating effects, suggesting potential utility as a treatment medication for marijuana dependence. This study will determine if naltrexone (0, 12, 25, 50, 100 mg) administration 45 min prior to marijuana administration (0, 3.27% THC) alters marijuana's subjective, cognitive or physiological effects. Marijuana smokers will spend approximately 5h/day for a total of 10 days in the outpatient laboratory. Participants will visit the outpatient laboratory 2-3 times per week, with a minimum 48-hr interval between sessions to allow for naltrexone clearance. These data will provide important information regarding the clinical use of naltrexone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Placebo, Marijuana (0% THC) | Placebo comparator | Drug: Placebo + Inactive Marijuana (0% THC)During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
| Placebo, Marijuana (3.27% THC) | Experimental | Drug: Placebo + Active Marijuana (3.27% THC)During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
| Naltrexone (12mg), Marijuana (0% THC) | Experimental | Drug: Naltrexone 12 Mg + Inactive Marijuana (0% THC)During each session, one capsule containing naltrexone (12 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
| Naltrexone (12mg), Marijuana (3.27% THC) | Experimental | Drug: Naltrexone 12 Mg+ Active Marijuana (3.27% THC)During each session, one capsule containing naltrexone (12 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
| Naltrexone (25mg), Marijuana (0% THC) | Experimental | Drug: Naltrexone 25 Mg + Inactive Marijuana (0% THC)During each session, one capsule containing naltrexone (25 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
| Naltrexone (25mg), Marijuana (3.27% THC) | Experimental | Drug: Naltrexone 25 Mg + Active Marijuana (3.27% THC)During each session, one capsule containing naltrexone (25 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
| Naltrexone (50mg), Marijuana (0% THC) | Experimental | Drug: Naltrexone 50 Mg + Inactive Marijuana (0% THC)During each session, one capsule containing naltrexone (50 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
| Naltrexone (50mg), Marijuana (3.27% THC) | Experimental | Drug: Naltrexone 50 Mg+ Active Marijuana (3.27% THC)During each session, one capsule containing naltrexone (50 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
| Naltrexone (100mg), Marijuana (0% THC) | Experimental | Drug: Naltrexone 100 Mg + Inactive Marijuana (0% THC)During each session, one capsule containing naltrexone (100 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
| Naltrexone (100mg), Marijuana (3.27% THC) | Experimental | Drug: Naltrexone 100 Mg+ Active Marijuana (3.27% THC)During each session, one capsule containing naltrexone (100 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Current marijuana use
- Able to perform study procedures
- 21-45 years of age
- Women practicing an effective form of birth control
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Placebo + Inactive Marijuana (0% THC)Also: treatment type 1One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration. | Drug | Placebo, Marijuana (0% THC) |
| Placebo + Active Marijuana (3.27% THC)Also: treatment type 2One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before administration of a marijuana cigarette containing 3.27% THC (ca. 800 mg) provided by the National Institute on Drug Abuse. | Drug | Placebo, Marijuana (3.27% THC) |
| Naltrexone 12 Mg+ Active Marijuana (3.27% THC)Also: Treatment type 3One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration. | Drug | Naltrexone (12mg), Marijuana (3.27% THC) |
| Naltrexone 25 Mg + Active Marijuana (3.27% THC)Also: treatment type 4One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration. | Drug | Naltrexone (25mg), Marijuana (3.27% THC) |
| Naltrexone 50 Mg+ Active Marijuana (3.27% THC)Also: treatment type 5One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration. | Drug | Naltrexone (50mg), Marijuana (3.27% THC) |
| Naltrexone 100 Mg+ Active Marijuana (3.27% THC)Also: treatment type 6One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration. | Drug | Naltrexone (100mg), Marijuana (3.27% THC) |
| Naltrexone 12 Mg + Inactive Marijuana (0% THC)Also: treatment type 7One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration. | Drug | Naltrexone (12mg), Marijuana (0% THC) |
| Naltrexone 25 Mg + Inactive Marijuana (0% THC)Also: treatment type 8One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration. | Drug | Naltrexone (25mg), Marijuana (0% THC) |
| Naltrexone 50 Mg + Inactive Marijuana (0% THC)Also: treatment type 9One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration. | Drug | Naltrexone (50mg), Marijuana (0% THC) |
| Naltrexone 100 Mg + Inactive Marijuana (0% THC)Also: treatment type 10One capsule containing 100mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration. | Drug | Naltrexone (100mg), Marijuana (0% THC) |
Primary outcome
Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose.
Time frame: Baseline compared to 6 week timepoint
All subjective effects were measured using visual analog scales (VAS), a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to rate their subjective experiences on the line according to how they felt at that particular moment. Subjective assessments included measures of perceived marijuana strength, marijuana "high", "good effects" of marijuana, and how much marijuana was "liked". Marijuana's effects were determined by comparing the active and inactive marijuana conditions when paired with the placebo naltrexone condition (one comparison). Naltrexone's intrinsic effects were assessed by comparing placebo and each active dose of naltrexone (12, 25, 50, and 100 mg) under the inactive marijuana condition (four comparisons). Finally, the active marijuana- placebo naltrexone condition was compared to the active marijuana-active naltrexone conditions (four comparisons)
Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose
Time frame: Baseline compared to 6 week timepoint
Change in Digit Symbol Substitution Test (DSST) scores. Increasing scores indicate improvement, on a scale of 0-90. The task batteries included total correct attempts on a 3-min DSST.
Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.
Time frame: Baseline compared to 6 week timepoint
Change in mean heart rate as a function of marijuana and naltrexone dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- 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.
Margaret Haney, Ph.D. principal investigator
New York State Psychiatric Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone 12 Mg+ Active Marijuana (3.27% THC), Naltrexone 25 Mg + Active Marijuana (3.27% THC) and Naltrexone 50 Mg+ Active Marijuana (3.27% THC) in people with Marijuana Use, run by New York State Psychiatric Institute.
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 4 inclusion and 10 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 15 Mar 2018. 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 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 19 Dec 2017). 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 Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. (time frame: Baseline compared to 6 week timepoint). The study lists 3 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 15 Mar 2018.