Marijuana DependencePhase 1NCT00893269
The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
A Phase 1 study testing eszopiclone, ramelteon and zolpidem in people with Marijuana Dependence, run by Johns Hopkins University at 1 site in United States.
Trial summary
Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Dependence
- What is being tested?
- eszopiclone, ramelteon and zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- current use of marijuana
- able to give informed consent
Who cannot join
- dependence on drug other than marijuana
- current sleep disorder
- pregnant, breast feeding, or planning to become pregnant within the next 3 months
- currently seeking treatment for cannabis-related problems or otherwise trying to reduce use
- use of cannabis under the guidance of a physician for a medical disorder
- unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina)
- allergy to study medication
Trial locations and contacts
1 site in 1 country.
About this study
Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function during brief periods of abstinence.
- Conditions
- Marijuana Dependence
- Being tested
- eszopiclone, Placebo, ramelteon, zolpidem
- Keywords
- marijuana, cannabis, dependence, withdrawal
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eszopicloneDrug
Oral capsule at dose recommended for adults
PlaceboDrug
Participants receive placebo prior to sleep
ramelteonDrug
ramelteon
zolpidemDrug
zolpidem
| Study group | Role | What they receive |
|---|---|---|
| Active Medication | Experimental | Participants receive active hypnotic medication prior to sleep Receives: Drug: eszopiclone; Drug: ramelteon; Drug: zolpidem |
| Placebo | Placebo comparator | Participants receive placebo prior to sleep Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana Withdrawal
Measured: Every day during study participation
Secondary outcomes (2)
Objective Sleep Assessment
Measured: Every day during study participation
Cognitive Performance
Measured: Every day during study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Marijuana DependenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ryan Vandrey, Johns Hopkins University
- Investigators
- Ryan Vandrey, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893269
- Sponsor's protocol ID
- NA_00017909
- Other IDs
- R21DA025794
- Status last verified
- Dec 2013
- First submitted
- 30 Apr 2009
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vandrey R, Umbricht A, Strain EC. Increased blood pressure after abrupt cessation of daily cannabis use. J Addict Med. 2011 Mar;5(1):16-20. doi: 10.1097/ADM.0b013e3181d2b309.
PubMed 21359104Vandrey R, Smith MT, McCann UD, Budney AJ, Curran EM. Sleep disturbance and the effects of extended-release zolpidem during cannabis withdrawal. Drug Alcohol Depend. 2011 Aug 1;117(1):38-44. doi: 10.1016/j.drugalcdep.2011.01.003. Epub 2011 Feb 5.
PubMed 21296508
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
- ClinicalTrials.gov ID
- NCT00893269
- Acronym / sponsor ID
- NA_00017909
- Conditions
- Marijuana Dependence
- Keywords
- marijuana, cannabis, dependence, withdrawal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function during brief periods of abstinence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Medication | Experimental | Drug: eszopiclone, Drug: ramelteon, Drug: zolpidemParticipants receive active hypnotic medication prior to sleep |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive placebo prior to sleep |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- current use of marijuana
- able to give informed consent
Key exclusion criteria (7 listed)
- dependence on drug other than marijuana
- current sleep disorder
- pregnant, breast feeding, or planning to become pregnant within the next 3 months
- currently seeking treatment for cannabis-related problems or otherwise trying to reduce use
- use of cannabis under the guidance of a physician for a medical disorder
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 |
|---|---|---|
| eszopicloneOral capsule at dose recommended for adults | Drug | Active Medication |
| PlaceboParticipants receive placebo prior to sleep | Drug | Placebo |
| ramelteonramelteon | Drug | Active Medication |
| zolpidemzolpidem | Drug | Active Medication |
Primary outcome
Marijuana Withdrawal
Time frame: Every day during study participation
2 secondary outcomes
Objective Sleep Assessment
Time frame: Every day during study participation
Cognitive Performance
Time frame: Every day during study participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
- Derived from this study: PubMed 21359104Vandrey R, Umbricht A, Strain EC. Increased blood pressure after abrupt cessation of daily cannabis use. J Addict Med. 2011 Mar;5(1):16-20. doi: 10.1097/ADM.0b013e3181d2b309.
- Derived from this study: PubMed 21296508Vandrey R, Smith MT, McCann UD, Budney AJ, Curran EM. Sleep disturbance and the effects of extended-release zolpidem during cannabis withdrawal. Drug Alcohol Depend. 2011 Aug 1;117(1):38-44. doi: 10.1016/j.drugalcdep.2011.01.003. Epub 2011 Feb 5.
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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.
Ryan Vandrey, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing eszopiclone, ramelteon and zolpidem in people with Marijuana Dependence, run by Johns Hopkins University at 1 site in United States.
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 2 inclusion and 7 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 5 Dec 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Marijuana Withdrawal (time frame: Every day during study participation). 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 NCT00893269, which also lists 2 linked publications.
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 5 Dec 2013.