Marijuana SmokingPhase 2NCT00743145

Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana

A Phase 2 study testing Inactive Marijuana (0% THC), Active Marijuana (5.5% THC) and Active Marijuana (6.2% THC) in people with Marijuana Smoking, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Marijuana Smoking
What is being tested?: Inactive Marijuana (0% THC), Active Marijuana (5.5% THC) and Active Marijuana (6.2% THC)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteUnited States
Study dates: May 2008to Sep 2009
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
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, hepatitis, clinically significant laboratory abnormalities, LFTs > 3x upper limit of normal, blood pressure > 140/90

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function for marijuana-elicited effects in heavy marijuana smokers. For this within-subject, double-blind study, a marijuana smoking procedure was designed to characterize a dose-response relationship for marijuana's subjective and cardiovascular effects under blinded conditions.

Conditions: Marijuana Smoking
Being tested: Inactive Marijuana (0% THC), Active Marijuana (5.5% THC), Active Marijuana (6.2% THC), Naltrexone, Placebo naltrexone
Keywords: naltrexone, smoked marijuana, marijuana use
Medical subject headings: Marijuana Smoking, Marijuana Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inactive Marijuana (0% THC)Drug
Also called Cannabis
Marijuana cigarette containing 0% THC
Active Marijuana (5.5% THC)Drug
Also called Cannabis
Marijuana cigarette containing 5.5% THC
Active Marijuana (6.2% THC)Drug
Also called Cannabis
Marijuana cigarette containing 6.2% THC
NaltrexoneDrug
Also called Revia
Naltrexone (12mg/70kg)
Placebo naltrexoneDrug
Also called PBO
Naltrexone (0mg)

Study groups in NCT00743145
Study group	Role	What they receive
Placebo naltrexone + Inactive marijuana	Placebo comparator	Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order. Receives: Drug: Inactive Marijuana (0% THC); Drug: Placebo naltrexone
Placebo naltrexone + Active marijuana (5.5% THC)	Placebo comparator	Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. Receives: Drug: Active Marijuana (5.5% THC); Drug: Placebo naltrexone
Placebo naltrexone + Active marijuana (6.2% THC)	Placebo comparator	Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order. Receives: Drug: Active Marijuana (6.2% THC); Drug: Placebo naltrexone
Naltrexone + Active marijuana (5.5% THC)	Experimental	Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. Receives: Drug: Active Marijuana (5.5% THC); Drug: Naltrexone
Naltrexone + Active marijuana (6.2% THC)	Experimental	Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order. Receives: Drug: Active Marijuana (6.2% THC); Drug: Naltrexone
Naltrexone + Inactive marijuana	Placebo comparator	Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order. Receives: Drug: Inactive Marijuana (0% THC); Drug: Naltrexone

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective Marijuana Effects
Subjective ratings of marijuana's quality and effect ('Strength', 'Good Effect', 'High', 'Stimulation') and craving ('Want Marijuana') as a function of active puffs and naltrexone, using a visual analogue scale with 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 indicate how they felt at that particular moment. Higher ratings indicate more agreement with the statement.
Measured: 180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Sep 2009

First posted28 Aug 2008 (estimated)
Study startMay 2008
Primary completionJul 2009
Study completionSep 2009

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 SmokingStudies 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00743145
Sponsor's protocol ID: IRB# 5693
Other IDs: DA19239
Status last verified: Aug 2018
First submitted: 26 Aug 2008
Last updated: 14 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Marijuana Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
ClinicalTrials.gov ID: NCT00743145
Acronym / sponsor ID: IRB# 5693
Conditions: Marijuana Smoking
Keywords: naltrexone, smoked marijuana, marijuana use
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 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: May 2008
Primary completion: Jul 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 28 Aug 2008 (estimated)
Results: Posted 14 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Placebo naltrexone + Inactive marijuana	Placebo comparator	Drug: Inactive Marijuana (0% THC), Drug: Placebo naltrexonePlacebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
Placebo naltrexone + Active marijuana (5.5% THC)	Placebo comparator	Drug: Active Marijuana (5.5% THC), Drug: Placebo naltrexonePlacebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
Placebo naltrexone + Active marijuana (6.2% THC)	Placebo comparator	Drug: Active Marijuana (6.2% THC), Drug: Placebo naltrexonePlacebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
Naltrexone + Active marijuana (5.5% THC)	Experimental	Drug: Active Marijuana (5.5% THC), Drug: NaltrexoneNaltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
Naltrexone + Active marijuana (6.2% THC)	Experimental	Drug: Active Marijuana (6.2% THC), Drug: NaltrexoneNaltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
Naltrexone + Inactive marijuana	Placebo comparator	Drug: Inactive Marijuana (0% THC), Drug: NaltrexoneNaltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.

Who may qualify

Ages: 21 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Current marijuana use
Able to perform study procedures
Women practicing an effective form of birth control

Key exclusion criteria (2 listed)

Current repeated illicit drug use (other than marijuana)
Presence of significant medical illness (e.g., diabetes, cardiovascular disease,hypertension, hepatitis, clinically significant laboratory abnormalities, LFTs > 3x upper limit of normal, blood pressure > 140/90

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
Inactive Marijuana (0% THC)Also: CannabisMarijuana cigarette containing 0% THC	Drug	Naltrexone + Inactive marijuana, Placebo naltrexone + Inactive marijuana
Active Marijuana (5.5% THC)Also: CannabisMarijuana cigarette containing 5.5% THC	Drug	Naltrexone + Active marijuana (5.5% THC), Placebo naltrexone + Active marijuana (5.5% THC)
Active Marijuana (6.2% THC)Also: CannabisMarijuana cigarette containing 6.2% THC	Drug	Naltrexone + Active marijuana (6.2% THC), Placebo naltrexone + Active marijuana (6.2% THC)
NaltrexoneAlso: ReviaNaltrexone (12mg/70kg)	Drug	Naltrexone + Active marijuana (5.5% THC), Naltrexone + Active marijuana (6.2% THC), Naltrexone + Inactive marijuana
Placebo naltrexoneAlso: PBONaltrexone (0mg)	Drug	Placebo naltrexone + Active marijuana (5.5% THC), Placebo naltrexone + Active marijuana (6.2% THC), Placebo naltrexone + Inactive marijuana

Primary outcome

Subjective Marijuana Effects
Time frame: 180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.
Subjective ratings of marijuana's quality and effect ('Strength', 'Good Effect', 'High', 'Stimulation') and craving ('Want Marijuana') as a function of active puffs and naltrexone, using a visual analogue scale with 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 indicate how they felt at that particular moment. Higher ratings indicate more agreement with the statement.

Results and safety

Results posted to the registry on 14 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo, Naltrexone, Marijuana	23	19

Primary outcome: Subjective Marijuana Effects

Time frame: 180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.. Mean (Standard Error). Unit: units on a scale (0-100mm)

Measure	Placebo Naltrexone + Inactive Marijuana n = 19	Placebo Naltrexone + Active Marijuana (5.5% THC) n = 19	Placebo Naltrexone + Active Marijuana (6.2% THC) n = 19	Naltrexone + Active Marijuana (5.5% THC) n = 19	Naltrexone + Active Marijuana (6.2% THC) n = 19	Naltrexone + Inactive Marijuana n = 19
"Marijuana Strength"	13 (1)	15 (1)	16 (2)	16 (2)	20 (2)	16 (2)
"Marijuana Good Effect"	14 (2)	37 (3)	30 (2.5)	31 (3)	46 (2)	26 (2)
"Marijuana High"	10 (1)	10.5 (0.5)	10 (1)	11 (1.5)	16 (1.5)	10 (1.5)
"Marijuana Stimulation"	16 (2)	20 (2)	16 (2)	20 (1.5)	30 (2)	22 (2)
"Want Marijuana"	50 (1.5)	48 (1)	37 (1.5)	49 (1)	45 (1.5)	50 (1.5)

Adverse events

Time frame: 4 weeks for each treatment and 1 week after receiving last treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Naltrexone + Inactive Marijuana (0.0% THC)	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Placebo Naltrexone + Active Marijuana (5.5% THC)	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Placebo Naltrexone + Active Marijuana (6.2% THC)	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Naltrexone + Inactive Marijuana (0.0% THC)	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Naltrexone + Active Marijuana (5.5% THC)	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Naltrexone + Active Marijuana (6.2% THC)	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Limitations and caveats (from the sponsor): This study is limited by its small sample size, and portion of males to females.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 14 Sep 2018). 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?

Subjective Marijuana Effects (time frame: 180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00743145.

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 14 Sep 2018.