Marijuana AbuseNCT00218478
Evaluating Responses to Drug-Related Cues Versus Neutral Cues to Understand the Effects of Marijuana Craving - 1
An observational study of Marijuana Abuse, run by Wayne State University at 1 site in United States.
Trial summary
The majority of past research on marijuana treatment has specifically targeted the alleviation of withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a role in treating marijuana addiction. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Abuse
- What is being tested?
- Cue Desensitization
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 2008
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Marijuana dependent volunteers
Who may be able to join
- Meets DSM-IV diagnosis criteria for marijuana dependence. Participants enrolled in the control group should not meet DSM-IV diagnosis criteria for any Axis I disorder, and should not use marijuana or have had limited marijuana exposure.
- Reads and writes English
- If female, willing to use adequate contraception throughout the study
Who cannot join
- Meets DSM-IV diagnosis criteria for a psychiatric illness
- History of a psychotic disorder
- Seeking treatment for marijuana dependence
- Neurologic disease, including structural brain abnormalities (e.g., neoplasms), stroke, seizures, infectious disease, head trauma resulting in unconsciousness, or evidence of neurologic illness resulting from HIV/AIDS
- Cardiovascular disease, including edema, chest pain or palpitations after exertion or drug use, myocardial infarction (heart attack), systolic blood pressure greater than 160 mmHg or less than 95 mmHg, or diastolic blood pressure greater than 95 mmHg
- Pulmonary disease, including apnea, cor pulmonale, tuberculosis, dyspnea, orthopnea, or tachypnea
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- Systemic disease, including endocrinopathies, kidney or liver failure, hypothyroidism, adrenocortical insufficiency, or an autoimmune disease involving the central nervous system
- Currently dependent on any drug other than marijuana or nicotine
- Cognitively impaired
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cue Reactivity Model for Assessing Pharmacologic Intervention in Treatment of Cannabis Use Disorders (Study 1)
The majority of past research on marijuana treatment has specifically targeted the alleviation of withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a role in treating marijuana addiction. The purpose of this study is to compare the effects of marijuana-related cues versus non marijuana-related cues in individuals both addicted and not addicted to marijuana. In turn, this may help establish a better understanding of the effects of marijuana cravings and may lead to improved treatments for marijuana dependence.
Read the detailed description
Marijuana is the most commonly used illegal drug in the United States; more than 2 million Americans either abuse or are dependent on the drug. The development of a medication to reduce marijuana use and prevent drug relapse by lessening withdrawal symptoms has been a primary focus of research. However, there has been little emphasis on evaluating the efficacy of a treatment that specifically reduces marijuana cravings. This study will evaluate the subjective and physiological responses to marijuana-related cues versus non marijuana-related cues in order to better understand the effects of marijuana cravings.
Participants will be divided into two groups. Group 1 will consist of 20 individuals diagnosed with marijuana dependence; Group 2 will consist of individuals matched by age range, gender and race to Group 1, and who are healthy volunteers and do not use marijuana or who report limited marijuana exposure. Participants in Group 1 will spend one night at the Psychiatric and Addiction Research Center at Detroit Receiving Hospital to control for alcohol and drug use for 12 hours preceding the next day's 2-hour study session. Participants in Group 2 are not required to spend the night, but are tested for drugs and alcohol prior to the session. During the study session, both groups will be shown a nature video and will be asked to handle and smell various items; these will act as the neutral, non marijuana-related cues. Next, the participants will watch a video of individuals smoking marijuana and will be asked to handle and smell marijuana-related items; these will act as the marijuana-related cues. Heart rate and skin temperature will be monitored continuously throughout the cue sessions with the use of electrodes and a skin thermometer. Prior to and after the cue sessions, blood pressure will be measured and questionnaires will be administered to assess drug cravings as well as related mood states. Prior to leaving the laboratory, the participants' vital signs will be evaluated to ensure that any cue-related physiological changes have returned to normal. Participants will have the option of talking to a clinician experienced in dealing with drug cravings following the end of the study session.
- Conditions
- Marijuana Abuse
- Being tested
- Cue Desensitization
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue DesensitizationBehavioural
During the study session, both groups will be shown a nature video and will be asked to handle and smell various items; these will act as the neutral, non marijuana-related cues. Next, the participants will watch a video of individuals smoking marijuana and will be asked to handle and smell marijuana-related items; these will act as the marijuana-related cues.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2004
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Leslie Lundahl, Wayne State University
- Investigators
- Leslie H. Lundahl, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218478
- Sponsor's protocol ID
- NIDA-19236-1
- Other IDs
- R21DA019236-01, DPMCDA
- Status last verified
- Jun 2012
- First submitted
- 16 Sep 2005
- Last updated
- 5 Jun 2012
- Results posted
- No
Publications
Lundahl LH, Greenwald MK. Magnitude and duration of cue-induced craving for marijuana in volunteers with cannabis use disorder. Drug Alcohol Depend. 2016 Sep 1;166:143-9. doi: 10.1016/j.drugalcdep.2016.07.004. Epub 2016 Jul 18.
PubMed 27436749
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cue Reactivity Model for Assessing Pharmacologic Intervention in Treatment of Cannabis Use Disorders (Study 1)
- ClinicalTrials.gov ID
- NCT00218478
- Acronym / sponsor ID
- NIDA-19236-1
- Conditions
- Marijuana Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2004
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Sep 2005 (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 majority of past research on marijuana treatment has specifically targeted the alleviation of withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a role in treating marijuana addiction. The purpose of this study is to compare the effects of marijuana-related cues versus non marijuana-related cues in individuals both addicted and not addicted to marijuana. In turn, this may help establish a better understanding of the effects of marijuana cravings and may lead to improved treatments for marijuana dependence.
Detailed description
Marijuana is the most commonly used illegal drug in the United States; more than 2 million Americans either abuse or are dependent on the drug. The development of a medication to reduce marijuana use and prevent drug relapse by lessening withdrawal symptoms has been a primary focus of research. However, there has been little emphasis on evaluating the efficacy of a treatment that specifically reduces marijuana cravings. This study will evaluate the subjective and physiological responses to marijuana-related cues versus non marijuana-related cues in order to better understand the effects of marijuana cravings.
Participants will be divided into two groups. Group 1 will consist of 20 individuals diagnosed with marijuana dependence; Group 2 will consist of individuals matched by age range, gender and race to Group 1, and who are healthy volunteers and do not use marijuana or who report limited marijuana exposure. Participants in Group 1 will spend one night at the Psychiatric and Addiction Research Center at Detroit Receiving Hospital to control for alcohol and drug use for 12 hours preceding the next day's 2-hour study session. Participants in Group 2 are not required to spend the night, but are tested for drugs and alcohol prior to the session. During the study session, both groups will be shown a nature video and will be asked to handle and smell various items; these will act as the neutral, non marijuana-related cues. Next, the participants will watch a video of individuals smoking marijuana and will be asked to handle and smell marijuana-related items; these will act as the marijuana-related cues. Heart rate and skin temperature will be monitored continuously throughout the cue sessions with the use of electrodes and a skin thermometer. Prior to and after the cue sessions, blood pressure will be measured and questionnaires will be administered to assess drug cravings as well as related mood states. Prior to leaving the laboratory, the participants' vital signs will be evaluated to ensure that any cue-related physiological changes have returned to normal. Participants will have the option of talking to a clinician experienced in dealing with drug cravings following the end of the study session.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Marijuana dependent volunteers
Key inclusion criteria (3 listed)
- Meets DSM-IV diagnosis criteria for marijuana dependence. Participants enrolled in the control group should not meet DSM-IV diagnosis criteria for any Axis I disorder, and should not use marijuana or have had limited marijuana exposure.
- Reads and writes English
- If female, willing to use adequate contraception throughout the study
Key exclusion criteria (10 listed)
- Meets DSM-IV diagnosis criteria for a psychiatric illness
- History of a psychotic disorder
- Seeking treatment for marijuana dependence
- Neurologic disease, including structural brain abnormalities (e.g., neoplasms), stroke, seizures, infectious disease, head trauma resulting in unconsciousness, or evidence of neurologic illness resulting from HIV/AIDS
- Cardiovascular disease, including edema, chest pain or palpitations after exertion or drug use, myocardial infarction (heart attack), systolic blood pressure greater than 160 mmHg or less than 95 mmHg, or diastolic blood pressure greater than 95 mmHg
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 |
|---|---|---|
| Cue DesensitizationDuring the study session, both groups will be shown a nature video and will be asked to handle and smell various items; these will act as the neutral, non marijuana-related cues. Next, the participants will watch a video of individuals smoking marijuana and will be asked to handle and smell marijuana-related items; these will act as the marijuana-related cues. | Behavioural | – |
Primary outcome
Not reported in the source record.
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 Jun 2012.
- Derived from this study: PubMed 27436749Lundahl LH, Greenwald MK. Magnitude and duration of cue-induced craving for marijuana in volunteers with cannabis use disorder. Drug Alcohol Depend. 2016 Sep 1;166:143-9. doi: 10.1016/j.drugalcdep.2016.07.004. Epub 2016 Jul 18.
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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.
Leslie H. Lundahl principal investigator
Wayne State University
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, run by Wayne State 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 3 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 5 Jun 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00218478, which also lists 1 linked publication.
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 Jun 2012.