Marijuana AbuseNCT01039415
Attempts to Stop/Reduce Marijuana Among Dependent Users
An observational study of Marijuana Abuse and Marijuana Dependence, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of the study is to determine why and how marijuana users stop or reduce their marijuana use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Marijuana Abuse, Marijuana Dependence
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2012
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults 18 and older
Who may be able to join
- daily marijuana smokers for at least 1 year
Who cannot join
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine why and how marijuana users stop or reduce their marijuana use.
Read the detailed description
The major aim of this study is to provide a better understanding of attempts to stop or reduce marijuana use that can be used to develop better behavioral treatments for marijuana dependence. The application will focus on adult daily marijuana users who try to stop or reduce their marijuana use in a real-world setting. Although prospective, natural history studies describing attempts to stop or reduce alcohol, heroin and tobacco use have proved useful, we know of no such study among adult marijuana users. Two pilot studies will develop measures and assess compliance with our procedures. The main study will recruit up to 400 adult marijuana smokers with the goal of a sample size of 200 participants with adequate compliance. Participants will call an Interactive Voice Recording (IVR) system daily for 3 months to report marijuana use, quit/reduction attempts, and events that might increase or decrease the probability of initiating a quit/reduction attempt or the success of an attempt. Follow-up at 6 months will track recent marijuana and other drug use. Knowing what motivates marijuana users to try to stop or reduce, and knowing which strategies for stopping marijuana use are successful, can help develop treatments for marijuana dependence. For example, if stopping tobacco when trying to stop marijuana decreases the chance of stopping marijuana, then smoking cessation should be done after stopping marijuana. Or if reducing marijuana often leads to cessation, then convincing those not interested in quitting marijuana to first try reducing may be helpful.
- Conditions
- Marijuana Abuse, Marijuana Dependence
- Keywords
- marijuana, marijuana abuse, marijuana dependence, cannabis, substance-related disorder, abstinence
- Medical subject headings
- Marijuana Abuse, Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
initiation of a quit or reduction attempt
Measured: during 3 months of monitoring
Secondary outcomes (1)
duration of a quit attempt
Measured: during the 3 months of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startJun 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Marijuana AbuseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, John Hughes, University of Vermont
- Investigators
- John Hughes, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039415
- Sponsor's protocol ID
- CHRBS #09-005
- Other IDs
- R01DA024691
- Status last verified
- Oct 2016
- First submitted
- 24 Dec 2009
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hughes JR, Fingar JR, Budney AJ, Naud S, Helzer JE, Callas PW. Marijuana use and intoxication among daily users: an intensive longitudinal study. Addict Behav. 2014 Oct;39(10):1464-70. doi: 10.1016/j.addbeh.2014.05.024. Epub 2014 Jun 4.
PubMed 24935797Hughes JR, Naud S, Budney AJ, Fingar JR, Callas PW. Attempts to stop or reduce daily cannabis use: An intensive natural history study. Psychol Addict Behav. 2016 May;30(3):389-97. doi: 10.1037/adb0000155. Epub 2016 Feb 1.
PubMed 26828641Hughes JR, Naud S, Budney AJ, Fingar JR, Callas PW. Environmental cues and attempts to change in daily cannabis users: An intensive longitudinal study. Drug Alcohol Depend. 2016 Apr 1;161:15-20. doi: 10.1016/j.drugalcdep.2015.09.033. Epub 2016 Feb 6.
PubMed 26872879
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attempts to Stop/Reduce Marijuana Among Dependent Users
- ClinicalTrials.gov ID
- NCT01039415
- Acronym / sponsor ID
- CHRBS #09-005
- Conditions
- Marijuana Abuse, Marijuana Dependence
- Keywords
- marijuana, marijuana abuse, marijuana dependence, cannabis, substance-related disorder, abstinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Dec 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.
The purpose of the study is to determine why and how marijuana users stop or reduce their marijuana use.
Detailed description
The major aim of this study is to provide a better understanding of attempts to stop or reduce marijuana use that can be used to develop better behavioral treatments for marijuana dependence. The application will focus on adult daily marijuana users who try to stop or reduce their marijuana use in a real-world setting. Although prospective, natural history studies describing attempts to stop or reduce alcohol, heroin and tobacco use have proved useful, we know of no such study among adult marijuana users. Two pilot studies will develop measures and assess compliance with our procedures. The main study will recruit up to 400 adult marijuana smokers with the goal of a sample size of 200 participants with adequate compliance. Participants will call an Interactive Voice Recording (IVR) system daily for 3 months to report marijuana use, quit/reduction attempts, and events that might increase or decrease the probability of initiating a quit/reduction attempt or the success of an attempt. Follow-up at 6 months will track recent marijuana and other drug use. Knowing what motivates marijuana users to try to stop or reduce, and knowing which strategies for stopping marijuana use are successful, can help develop treatments for marijuana dependence. For example, if stopping tobacco when trying to stop marijuana decreases the chance of stopping marijuana, then smoking cessation should be done after stopping marijuana. Or if reducing marijuana often leads to cessation, then convincing those not interested in quitting marijuana to first try reducing may be helpful.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults 18 and older
Key inclusion criteria (1 listed)
- daily marijuana smokers for at least 1 year
Key exclusion criteria (1 listed)
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
initiation of a quit or reduction attempt
Time frame: during 3 months of monitoring
1 secondary outcome
duration of a quit attempt
Time frame: during the 3 months of monitoring
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 31 Oct 2016.
- Results publication: PubMed 24935797Hughes JR, Fingar JR, Budney AJ, Naud S, Helzer JE, Callas PW. Marijuana use and intoxication among daily users: an intensive longitudinal study. Addict Behav. 2014 Oct;39(10):1464-70. doi: 10.1016/j.addbeh.2014.05.024. Epub 2014 Jun 4.
- Results publication: PubMed 26828641Hughes JR, Naud S, Budney AJ, Fingar JR, Callas PW. Attempts to stop or reduce daily cannabis use: An intensive natural history study. Psychol Addict Behav. 2016 May;30(3):389-97. doi: 10.1037/adb0000155. Epub 2016 Feb 1.
- Results publication: PubMed 26872879Hughes JR, Naud S, Budney AJ, Fingar JR, Callas PW. Environmental cues and attempts to change in daily cannabis users: An intensive longitudinal study. Drug Alcohol Depend. 2016 Apr 1;161:15-20. doi: 10.1016/j.drugalcdep.2015.09.033. Epub 2016 Feb 6.
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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.
John Hughes, MD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marijuana Abuse and Marijuana Dependence, run by University of Vermont 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 1 inclusion and 1 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 31 Oct 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
initiation of a quit or reduction attempt (time frame: during 3 months of monitoring). 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 NCT01039415, which also lists 3 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 31 Oct 2016; AzTrials last refreshed its copy on 31 Oct 2026.