Cannabis AbusePhase 2NCT01110434
Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents
A Phase 2 study testing Topiramate in people with Cannabis Abuse and Cannabis Dependence, run by Brown University at 1 site in United States.
Trial summary
Cannabis use is a significant public health concern that disproportionately affect youth. Although promising psychosocial interventions are being developed, most youth do not benefit from these interventions alone. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Abuse, Cannabis Dependence
- What is being tested?
- Topiramate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to May 2012
- Phase
- Phase 2
- 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 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 15 to 20 years old (inclusive)
- Non-treatment seeking for cannabis abuse or dependence
- Able to read English, understand their rights as provided by the informed consent process, and be willing to sign an informed consent form to participant in the study
- If younger than 18 years old, informed consent from a parent or legal guardian is required
- Used cannabis at least 2 days per week during the past 30 days
Who cannot join
- Treatment seeking or a recent history of treatment for cannabis abuse or dependence
- Endorses a current commitment to stop using cannabis
- Clinically significant physical abnormalities as indicated by physical exam, hematological assessment, bilirubin concentration or urinalysis
- History of renal impairment, renal stones, seizures, or unstable hypertension
- Underweight (i.e., less than the 5th percentile) or overweight (equal to or greater than the 95th percentile), as determined by the Body Mass Index
- Positive urine toxicology screen for narcotics, amphetamines, or sedative hypnotics or self-reported drug use, other than cannabis, alcohol or nicotine, in the past 30 days
Show all 14Show fewer
- Pregnant, nursing, or refusal to use reliable barrier method of birth control (e.g., condom), if female
- Took a psychotropic medication in the past 30 days
- Taking medications with a potential effect on cannabis use or a carbonic anhydrase inhibitor
- Suicidal
- A current DSM-IV-TR Axis I diagnosis other than attention- deficit/hyperactivity disorder or a disruptive behavior disorder
- A current substance use disorder other than a cannabis, alcohol, and nicotine use disorders
- Significant alcohol withdrawal symptoms
- Known sensitivity to topiramate
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University, Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02912
About this study
Cannabis use is a significant public health concern that disproportionately affect youth. Although promising psychosocial interventions are being developed, most youth do not benefit from these interventions alone. Given the clinical demand for effective treatments, the National Institute on Drug Abuse (NIDA) identified the critical need for data on the tolerability and potential efficacy of medications in adolescents. The purpose of this two-year study is to test if and how topiramate, a medication under intense study for treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for the 6-week period using handheld electronic diaries and complete assessments of reactivity to cannabis-related cues.
- Conditions
- Cannabis Abuse, Cannabis Dependence
- Being tested
- Topiramate, Placebo
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Also called Topamax
Topiramate (200 mg daily)
PlaceboDrug
Placebo (daily)
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | Topiramate (200 mg daily) Receives: Drug: Topiramate |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis Use
Frequency of Cannabis Use (Percent Use Days Per Week)
Measured: Weeks 1-6
Secondary outcomes (2)
Quantity of Cannabis Use
Total Grams of Cannabis Use Per week
Measured: Weeks 1-6
Amount of Cannabis Use Per Use Day
Average Grams of Cannabis Used Per Use Day
Measured: Weeks 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionMay 2012
- Study completionMay 2012
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cannabis AbuseStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Robert Miranda, Brown University
- Investigators
- Robert Miranda, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110434
- Sponsor's protocol ID
- R01DA026778
- Other IDs
- R01DA026778
- Status last verified
- Aug 2020
- First submitted
- 20 Apr 2010
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Meisel SN, Carpenter RW, Treloar Padovano H, Miranda R. Day-level shifts in social contexts during youth cannabis use treatment. J Consult Clin Psychol. 2021 Apr;89(4):251-263. doi: 10.1037/ccp0000647.
PubMed 34014688Treloar Padovano H, Miranda R. Subjective cannabis effects as part of a developing disorder in adolescents and emerging adults. J Abnorm Psychol. 2018 Apr;127(3):282-293. doi: 10.1037/abn0000342.
PubMed 29672090
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents
- ClinicalTrials.gov ID
- NCT01110434
- Acronym / sponsor ID
- R01DA026778
- Conditions
- Cannabis Abuse, Cannabis Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cannabis use is a significant public health concern that disproportionately affect youth. Although promising psychosocial interventions are being developed, most youth do not benefit from these interventions alone. Given the clinical demand for effective treatments, the National Institute on Drug Abuse (NIDA) identified the critical need for data on the tolerability and potential efficacy of medications in adolescents. The purpose of this two-year study is to test if and how topiramate, a medication under intense study for treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for the 6-week period using handheld electronic diaries and complete assessments of reactivity to cannabis-related cues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Experimental | Drug: TopiramateTopiramate (200 mg daily) |
| Sugar pill | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 15 to 20 years old (inclusive)
- Non-treatment seeking for cannabis abuse or dependence
- Able to read English, understand their rights as provided by the informed consent process, and be willing to sign an informed consent form to participant in the study
- If younger than 18 years old, informed consent from a parent or legal guardian is required
- Used cannabis at least 2 days per week during the past 30 days
Key exclusion criteria (14 listed)
- Treatment seeking or a recent history of treatment for cannabis abuse or dependence
- Endorses a current commitment to stop using cannabis
- Clinically significant physical abnormalities as indicated by physical exam, hematological assessment, bilirubin concentration or urinalysis
- History of renal impairment, renal stones, seizures, or unstable hypertension
- Underweight (i.e., less than the 5th percentile) or overweight (equal to or greater than the 95th percentile), as determined by the Body Mass Index
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 |
|---|---|---|
| TopiramateAlso: TopamaxTopiramate (200 mg daily) | Drug | Topiramate |
| PlaceboPlacebo (daily) | Drug | Sugar pill |
Primary outcome
Cannabis Use
Time frame: Weeks 1-6
Frequency of Cannabis Use (Percent Use Days Per Week)
2 secondary outcomes
Quantity of Cannabis Use
Time frame: Weeks 1-6
Amount of Cannabis Use Per Use Day
Time frame: Weeks 1-6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34014688Meisel SN, Carpenter RW, Treloar Padovano H, Miranda R. Day-level shifts in social contexts during youth cannabis use treatment. J Consult Clin Psychol. 2021 Apr;89(4):251-263. doi: 10.1037/ccp0000647.
- Derived from this study: PubMed 29672090Treloar Padovano H, Miranda R. Subjective cannabis effects as part of a developing disorder in adolescents and emerging adults. J Abnorm Psychol. 2018 Apr;127(3):282-293. doi: 10.1037/abn0000342.
Related trials for Cannabis Abuse
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
Cannabis Dependence, Harmful Use
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.
Robert Miranda, Ph.D. principal investigator
Brown University
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 Topiramate in people with Cannabis Abuse and Cannabis Dependence, run by Brown 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 5 inclusion and 14 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 16 Sep 2020. 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 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?
Yes. Results are posted in the registry (first posted 16 Sep 2020). 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?
Cannabis Use (time frame: Weeks 1-6). 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 NCT01110434, which also lists 2 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 16 Sep 2020.