Cannabis AbuseNCT01603992
Quiting Marijuana Use: Self-report Study of Quitting Straegies and Withdrawal Symptoms
An observational study of Cannabis Abuse and Cannabis Dependence, run by National Institute on Drug Abuse (NIDA) at 3 sites in United States.
Trial summary
Background: Marijuana is the most widely used illicit drug in the world, yet relatively little is known about users who try to quit without formal treatment ( spontaneous quitting). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cannabis Abuse, Cannabis Dependence
- How many people
- 822 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Nov 2005to 3 May 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or older
- have made at least one attempt to quit marijuana use
- able to give valid informed consent
- ability to understand English
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue
Catonsville, Maryland, 21228
Medical University of S. Carolina
Charleston, South Carolina, 29425
About this study
Official title: Quitting Marijuana Use: Self-Report Study of Quitting Strategies and Withdrawal Symptoms
Background:
- Marijuana is the most widely used illicit drug in the world, yet relatively little is known about users who try to quit without formal treatment ( spontaneous quitting). Studies have suggested that there are some common strategies that many individuals use in spontaneous quitting, such as changing one s lifestyle or identity, reminding oneself of negative consequences, support from family and friends, and religion. However, more research is needed to determine potential treatment strategies for marijuana use.
Read more
Objectives:
- To identify strategies used to help with marijuana quitting among non-treatment seeking adult marijuana users.
- To identify withdrawal symptoms experienced during marijuana quitting and their relationship to the quitting strategies used and the outcome of the quit attempt.
- To evaluate whether subgroups of marijuana users differ in their experience of marijuana quitting.
Eligibility:
- Individuals at least 18 years of age who have made at least one attempt to quit marijuana use.
Design:
- The study will consist of one visit of approximately 1 to 2 hours.
- Participants will fill out three questionnaires. The questionnaires have different types of questions, and will ask about background and lifestyle, marijuana use and craving patterns and behaviors, and difficulties in previous attempts to quit using marijuana.
Read the detailed description
Marijuana is the most widely used illicit drug in the world, yet relatively little is known about users who try to quit without formal treatment (so-called spontaneous quitting). This study will use two self-report questionnaires to collect information on the socio-demographic characteristics, marijuana use history, most difficult marijuana quit experience, and marijuana craving from a convenience sample of 1230 adult, non-treatment-seeking marijuana users. The questionnaires take 45-60 minutes to administer. Data will be analyzed for patterns and correlations among the characteristics of the quit attempt, including any withdrawal symptoms, quitting strategies used, and its success. The marijuana craving data will be analyzed to evaluate the validity of this measure of marijuana craving. There are no direct benefits to subjects from study participation. The scientific benefit is an improved understanding of spontaneous quitting of marijuana use, which may lead to improved interventions for marijuana users in the future. There are no physical risks to subjects. There are risks of anxiety or embarrassment while taking the questionnaire and of loss of confidentiality of sensitive information collected about subjects.
- Conditions
- Cannabis Abuse, Cannabis Dependence
- Keywords
- Cannabis, Craving, Questionnaire, Non-Treatment, Drug Use
- Medical subject headings
- Marijuana Abuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana Quit Questionnaire
Measured: 1 to 2 hours
Secondary outcomes (1)
Marijuana Craving Questionnaire, and Additional Questions about Marijuana Craving
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study start8 Nov 2005
- Study completion3 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cannabis 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
- Enrolment
- 822 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- David A Gorelick, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603992
- Sponsor's protocol ID
- 999906408
- Other IDs
- 06-DA-N408
- Status last verified
- 3 May 2012
- First submitted
- 19 May 2012
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Adamson SJ, Sellman JD. A prototype screening instrument for cannabis use disorder: the Cannabis Use Disorders Identification Test (CUDIT) in an alcohol-dependent clinical sample. Drug Alcohol Rev. 2003 Sep;22(3):309-15. doi: 10.1080/0959523031000154454.
PubMed 15385225Boyd SJ, Tashkin DP, Huestis MA, Heishman SJ, Dermand JC, Simmons MS, Gorelick DA. Strategies for quitting among non-treatment-seeking marijuana smokers. Am J Addict. 2005 Jan-Feb;14(1):35-42. doi: 10.1080/10550490590899835.
PubMed 15804875Budney AJ, Hughes JR, Moore BA, Vandrey R. Review of the validity and significance of cannabis withdrawal syndrome. Am J Psychiatry. 2004 Nov;161(11):1967-77. doi: 10.1176/appi.ajp.161.11.1967.
PubMed 15514394Koola MM, Boggs DL, Kelly DL, Liu F, Linthicum JA, Turner HE, McMahon RP, Gorelick DA. Relief of cannabis withdrawal symptoms and cannabis quitting strategies in people with schizophrenia. Psychiatry Res. 2013 Oct 30;209(3):273-8. doi: 10.1016/j.psychres.2013.07.044. Epub 2013 Aug 20.
PubMed 23969281Boggs DL, Kelly DL, Liu F, Linthicum JA, Turner H, Schroeder JR, McMahon RP, Gorelick DA. Cannabis withdrawal in chronic cannabis users with schizophrenia. J Psychiatr Res. 2013 Feb;47(2):240-5. doi: 10.1016/j.jpsychires.2012.10.010. Epub 2012 Nov 10.
PubMed 23146560
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quitting Marijuana Use: Self-Report Study of Quitting Strategies and Withdrawal Symptoms
- ClinicalTrials.gov ID
- NCT01603992
- Acronym / sponsor ID
- 999906408
- Conditions
- Cannabis Abuse, Cannabis Dependence
- Keywords
- Cannabis, Craving, Questionnaire, Non-Treatment, Drug Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 822 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 8 Nov 2005
- Study completion
- 3 May 2012
- First posted
- 23 May 2012 (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.
Background:
- Marijuana is the most widely used illicit drug in the world, yet relatively little is known about users who try to quit without formal treatment ( spontaneous quitting). Studies have suggested that there are some common strategies that many individuals use in spontaneous quitting, such as changing one s lifestyle or identity, reminding oneself of negative consequences, support from family and friends, and religion. However, more research is needed to determine potential treatment strategies for marijuana use.
Objectives:
- To identify strategies used to help with marijuana quitting among non-treatment seeking adult marijuana users.
- To identify withdrawal symptoms experienced during marijuana quitting and their relationship to the quitting strategies used and the outcome of the quit attempt.
- To evaluate whether subgroups of marijuana users differ in their experience of marijuana quitting.
Eligibility:
- Individuals at least 18 years of age who have made at least one attempt to quit marijuana use.
Design:
- The study will consist of one visit of approximately 1 to 2 hours.
- Participants will fill out three questionnaires. The questionnaires have different types of questions, and will ask about background and lifestyle, marijuana use and craving patterns and behaviors, and difficulties in previous attempts to quit using marijuana.
Detailed description
Marijuana is the most widely used illicit drug in the world, yet relatively little is known about users who try to quit without formal treatment (so-called spontaneous quitting). This study will use two self-report questionnaires to collect information on the socio-demographic characteristics, marijuana use history, most difficult marijuana quit experience, and marijuana craving from a convenience sample of 1230 adult, non-treatment-seeking marijuana users. The questionnaires take 45-60 minutes to administer. Data will be analyzed for patterns and correlations among the characteristics of the quit attempt, including any withdrawal symptoms, quitting strategies used, and its success. The marijuana craving data will be analyzed to evaluate the validity of this measure of marijuana craving. There are no direct benefits to subjects from study participation. The scientific benefit is an improved understanding of spontaneous quitting of marijuana use, which may lead to improved interventions for marijuana users in the future. There are no physical risks to subjects. There are risks of anxiety or embarrassment while taking the questionnaire and of loss of confidentiality of sensitive information collected about subjects.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (0 listed)
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
Marijuana Quit Questionnaire
Time frame: 1 to 2 hours
1 secondary outcome
Marijuana Craving Questionnaire, and Additional Questions about Marijuana Craving
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 Apr 2018.
- Background: PubMed 15385225Adamson SJ, Sellman JD. A prototype screening instrument for cannabis use disorder: the Cannabis Use Disorders Identification Test (CUDIT) in an alcohol-dependent clinical sample. Drug Alcohol Rev. 2003 Sep;22(3):309-15. doi: 10.1080/0959523031000154454.
- Background: PubMed 15804875Boyd SJ, Tashkin DP, Huestis MA, Heishman SJ, Dermand JC, Simmons MS, Gorelick DA. Strategies for quitting among non-treatment-seeking marijuana smokers. Am J Addict. 2005 Jan-Feb;14(1):35-42. doi: 10.1080/10550490590899835.
- Background: PubMed 15514394Budney AJ, Hughes JR, Moore BA, Vandrey R. Review of the validity and significance of cannabis withdrawal syndrome. Am J Psychiatry. 2004 Nov;161(11):1967-77. doi: 10.1176/appi.ajp.161.11.1967.
- Derived from this study: PubMed 23969281Koola MM, Boggs DL, Kelly DL, Liu F, Linthicum JA, Turner HE, McMahon RP, Gorelick DA. Relief of cannabis withdrawal symptoms and cannabis quitting strategies in people with schizophrenia. Psychiatry Res. 2013 Oct 30;209(3):273-8. doi: 10.1016/j.psychres.2013.07.044. Epub 2013 Aug 20.
- Derived from this study: PubMed 23146560Boggs DL, Kelly DL, Liu F, Linthicum JA, Turner H, Schroeder JR, McMahon RP, Gorelick DA. Cannabis withdrawal in chronic cannabis users with schizophrenia. J Psychiatr Res. 2013 Feb;47(2):240-5. doi: 10.1016/j.jpsychires.2012.10.010. Epub 2012 Nov 10.
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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.
David A Gorelick, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis Abuse and Cannabis Dependence, run by National Institute on Drug Abuse (NIDA) at 3 sites 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 4 inclusion and 0 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Marijuana Quit Questionnaire (time frame: 1 to 2 hours). 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 NCT01603992, which also lists 5 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 Apr 2018.