Marijuana DependencePhase 4NCT00875836

Buspirone Treatment for Marijuana Dependence

A Phase 4 study testing Buspirone in people with Marijuana Dependence, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Marijuana Dependence
What is being tested?: Buspirone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 175 participants
Where: 1 siteUnited States
Study dates: Sep 2009to Mar 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Must meet DSM-IV criteria for marijuana dependence.
Must be between the ages of 18 and 65 years.
If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial.
Must consent to random assignment, and be willing to commit to psychosocial behavioral and medication treatment.
Must be able to read and provide informed consent.

Who cannot join

Women who are pregnant, nursing, or plan to become pregnant during the course of the study.
Must not have a history of or current psychotic disorder, bipolar disorder, or eating disorder.
Must not pose a current suicidal or homicidal risk.
Must not meet current criteria for major depression.
Must not have evidence or history of serious hematologic, endocrine, cardiovascular, pulmonary, renal, gastrointestinal or neurologic disease.
Must not require concomitant therapy with psychotropic medication.

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Must not be currently dependent on other substances, with the exception of nicotine or caffeine.
Hypersensitivity to buspirone or any other product component.
Patients who, in the investigator's opinion, would be unable to comply with study procedures or assessments, or would be unacceptable study candidates (e.g., poses threat to staff).

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of buspirone for reducing marijuana use in marijuana-dependent adults. A contingency management (CM) intervention and motivational enhancement therapy (MET) will be incorporated to encourage study engagement and retention. It is hypothesized that buspirone combined with MET and CM will reduce the percent of marijuana-positive urine drug screen results in marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.

Conditions: Marijuana Dependence
Being tested: Buspirone, Placebo
Keywords: Marijuana, Buspirone, Contingency management, Motivational enhancement therapy
Medical subject headings: Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BuspironeDrug
Also called Buspar
Flexible dose, up to 60 mg daily
PlaceboDrug
Flexible dose, up to 60 mg daily

Study groups in NCT00875836
Study group	Role	What they receive
Buspirone	Experimental	Buspirone Receives: Drug: Buspirone
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Marijuana-negative Urine Drug Screens (UDS)
Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.
Measured: Participants provided a once-weekly urine sample for twelve weeks

Secondary outcomes (2)

Retention in the Study
Number of days subjects remained active in the study
Measured: participants were followed for twelve weeks
Marijuana Craving
The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) - 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly- reported here is the mean composite score across the 8 week treatment course.
Measured: 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Mar 2016

First posted3 Apr 2009 (estimated)
Study startSep 2009
Primary completionJun 2014
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Marijuana DependenceStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00875836
Sponsor's protocol ID: R01DA026782
Other IDs: R01DA026782, DPMCDA
Status last verified: Jul 2016
First submitted: 2 Apr 2009
Last updated: 10 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
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Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
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Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Neuroimaging of Adolescent Cannabis Use Treatment
Cannabis Use, Cannabis Dependence

All Marijuana Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Buspirone Treatment for Marijuana Dependence
ClinicalTrials.gov ID: NCT00875836
Acronym / sponsor ID: R01DA026782
Conditions: Marijuana Dependence
Keywords: Marijuana, Buspirone, Contingency management, Motivational enhancement therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Sep 2009
Primary completion: Jun 2014 (actual)
Study completion: Mar 2016 (actual)
First posted: 3 Apr 2009 (estimated)
Results: Posted 9 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Buspirone	Experimental	Drug: BuspironeBuspirone
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Must meet DSM-IV criteria for marijuana dependence.
Must be between the ages of 18 and 65 years.
If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial.
Must consent to random assignment, and be willing to commit to psychosocial behavioral and medication treatment.
Must be able to read and provide informed consent.

Key exclusion criteria (9 listed)

Women who are pregnant, nursing, or plan to become pregnant during the course of the study.
Must not have a history of or current psychotic disorder, bipolar disorder, or eating disorder.
Must not pose a current suicidal or homicidal risk.
Must not meet current criteria for major depression.
Must not have evidence or history of serious hematologic, endocrine, cardiovascular, pulmonary, renal, gastrointestinal or neurologic disease.

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
BuspironeAlso: BusparFlexible dose, up to 60 mg daily	Drug	Buspirone
PlaceboFlexible dose, up to 60 mg daily	Drug	Placebo

Primary outcome

Percent Marijuana-negative Urine Drug Screens (UDS)
Time frame: Participants provided a once-weekly urine sample for twelve weeks
Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.

2 secondary outcomes

Retention in the Study
Time frame: participants were followed for twelve weeks
Marijuana Craving
Time frame: 8 Weeks

Results and safety

Results posted to the registry on 9 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Buspirone	88	45
Placebo	87	47

Primary outcome: Percent Marijuana-negative Urine Drug Screens (UDS)

Time frame: Participants provided a once-weekly urine sample for twelve weeks. Number. Unit: percentage of UDS

Measure	Buspirone n = 88	Placebo n = 87
Value	7.2	6.4

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Buspirone	0 of 88 (0%)	73 of 88 (83%)	Not reported
Placebo	0 of 87 (0%)	66 of 87 (75.9%)	Not reported

Limitations and caveats (from the sponsor): Limitations included significant attrition during the course of the 12-week trial, difficulty with UCT interpretation due to the long excretion half-life of marijuana in urine, and likelihood that the genetic analysis was underpowered.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Marijuana Dependence

Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
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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-Clark, 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 4 study testing Buspirone in people with Marijuana Dependence, 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 5 inclusion and 9 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 10 Aug 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Marijuana-negative Urine Drug Screens (UDS) (time frame: Participants provided a once-weekly urine sample for twelve weeks). 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 NCT00875836.

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 10 Aug 2016; AzTrials last refreshed its copy on 31 Oct 2026.