Marijuana AbusePhase 2NCT00149617
Effectiveness of Buspirone and Motivational Enhancement Therapy for the Treatment of Marijuana Dependence - 1
A Phase 2 study testing Buspirone in people with Marijuana Abuse and Mood Disorders, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will assess the effectiveness of a combination of buspirone and motivational interviewing therapy in the treatment of marijuana dependence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Marijuana Abuse, Mood Disorders
- What is being tested?
- Buspirone
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2007
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for marijuana dependence
- Lives within 60 miles of the study site
- Willing to provide collateral individuals for contact purposes
- Willing to use an effective form of contraception throughout the study
Who cannot join
- Meets DSM-IV criteria for dependence upon a substance other than marijuana, nicotine, or caffeine
- Meets DSM-IV criteria for a history of schizophrenia or another non-affective psychotic disorder or bipolar disorder
- Meets DSM-IV criteria for current major depressive disorder or eating disorder
- Significant cognitive impairment
- Currently taking benzodiazepines, antidepressant, or antipsychotic medications
- Major medical illnesses (e.g., HIV, kidney failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis)
- Not in stable housing
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Career Training in Marijuana Dependence
This study will assess the effectiveness of a combination of buspirone and motivational interviewing therapy in the treatment of marijuana dependence.
Read the detailed description
Marijuana dependence is one of the most common substance-related disorders in the United States. Despite its prevalence, there is a lack of clinical research addressing treatments for marijuana dependence. Research has shown that marijuana abuse is associated with affective disorders. This may be caused by repeated use for relief from anxiety. The use of an anxiolytic agent, a drug that relieves anxiety, may help treat marijuana dependence. Motivational enhancement therapy has been shown to reduce marijuana use. Therefore, it is likely that buspirone, which is an anxiolytic agent, combined with motivational enhancement therapy will prove beneficial in treating marijuana dependence. This study will assess the effectiveness of a combination of buspirone and motivational interviewing in the treatment of marijuana dependence.
This double-blind study will last a total of 16 weeks. Participants will be randomly assigned to receive either buspirone or placebo for a period of 12 weeks. There will be one follow-up appointment 4 weeks post-intervention. Baseline assessments will include a physical exam and urine and blood tests. Study visits will occur weekly throughout treatment in order to monitor compliance, assess adverse affects, and obtain substance use data. Mood assessment scales, marijuana craving questionnaires, and a withdrawal symptom checklist will be used to gather the data. Urine drug screens will be collected weekly to test for marijuana use. In addition to this, the presence of opioids, cocaine, amphetamines, and benzodiazepines will be tested at baseline, Weeks 6 and 12, and at follow-up. A 10-day supply of medication will be dispensed to participants each week. Meetings for motivational enhancement therapy will last 30 to 90 minutes each and will occur at baseline, Week 2, and Week 4. Participants' perceived quality of life will be measured at baseline and Weeks 6 and 12 to determine the effect of buspirone.
- Conditions
- Marijuana Abuse, Mood Disorders
- Being tested
- Buspirone
- Keywords
- Marijuana, Mood Disorder
- Medical subject headings
- Marijuana Abuse, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use; measured at Weeks 12 and 16
Secondary outcomes (3)
Anxiety; measured at Week 12
Craving; measured at Week 12
Withdrawal symptoms; measured at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startApr 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana AbuseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Aimee Mcrae, Pharm.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149617
- Sponsor's protocol ID
- NIDA-15440-1
- Other IDs
- K23DA015440, K23-15440-1, DPMC
- Status last verified
- Dec 2007
- First submitted
- 6 Sep 2005
- Last updated
- 9 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Career Training in Marijuana Dependence
- ClinicalTrials.gov ID
- NCT00149617
- Acronym / sponsor ID
- NIDA-15440-1
- Conditions
- Marijuana Abuse, Mood Disorders
- Keywords
- Marijuana, Mood Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2004
- Study completion
- Dec 2007 (actual)
- First posted
- 8 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.
This study will assess the effectiveness of a combination of buspirone and motivational interviewing therapy in the treatment of marijuana dependence.
Detailed description
Marijuana dependence is one of the most common substance-related disorders in the United States. Despite its prevalence, there is a lack of clinical research addressing treatments for marijuana dependence. Research has shown that marijuana abuse is associated with affective disorders. This may be caused by repeated use for relief from anxiety. The use of an anxiolytic agent, a drug that relieves anxiety, may help treat marijuana dependence. Motivational enhancement therapy has been shown to reduce marijuana use. Therefore, it is likely that buspirone, which is an anxiolytic agent, combined with motivational enhancement therapy will prove beneficial in treating marijuana dependence. This study will assess the effectiveness of a combination of buspirone and motivational interviewing in the treatment of marijuana dependence.
This double-blind study will last a total of 16 weeks. Participants will be randomly assigned to receive either buspirone or placebo for a period of 12 weeks. There will be one follow-up appointment 4 weeks post-intervention. Baseline assessments will include a physical exam and urine and blood tests. Study visits will occur weekly throughout treatment in order to monitor compliance, assess adverse affects, and obtain substance use data. Mood assessment scales, marijuana craving questionnaires, and a withdrawal symptom checklist will be used to gather the data. Urine drug screens will be collected weekly to test for marijuana use. In addition to this, the presence of opioids, cocaine, amphetamines, and benzodiazepines will be tested at baseline, Weeks 6 and 12, and at follow-up. A 10-day supply of medication will be dispensed to participants each week. Meetings for motivational enhancement therapy will last 30 to 90 minutes each and will occur at baseline, Week 2, and Week 4. Participants' perceived quality of life will be measured at baseline and Weeks 6 and 12 to determine the effect of buspirone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets DSM-IV criteria for marijuana dependence
- Lives within 60 miles of the study site
- Willing to provide collateral individuals for contact purposes
- Willing to use an effective form of contraception throughout the study
Key exclusion criteria (8 listed)
- Meets DSM-IV criteria for dependence upon a substance other than marijuana, nicotine, or caffeine
- Meets DSM-IV criteria for a history of schizophrenia or another non-affective psychotic disorder or bipolar disorder
- Meets DSM-IV criteria for current major depressive disorder or eating disorder
- Significant cognitive impairment
- Currently taking benzodiazepines, antidepressant, or antipsychotic medications
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 |
|---|---|---|
| Buspirone | Drug | – |
Primary outcome
Drug use; measured at Weeks 12 and 16
3 secondary outcomes
Anxiety; measured at Week 12
Craving; measured at Week 12
Withdrawal symptoms; measured at Week 12
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 9 Oct 2015.
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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.
Aimee Mcrae, Pharm.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buspirone in people with Marijuana Abuse and Mood Disorders, run by Medical University of South Carolina 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 4 inclusion and 8 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 9 Oct 2015. 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.
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?
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?
Drug use; measured at Weeks 12 and 16. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2015.