Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Miranda, Brown University
ClinicalTrials.gov Identifier:
NCT01110434
First received: April 20, 2010
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Cannabis Abuse
Cannabis Dependence
Drug: Topiramate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Cannabis Use [ Time Frame: Daily for 6 weeks ] [ Designated as safety issue: No ]
    Quantity and frequency of cannabis use among adolescents in their natural environments


Secondary Outcome Measures:
  • Surface Eye Blink Electromyography (EMG) [ Time Frame: 1 and 6 weeks ] [ Designated as safety issue: No ]
    Surface eye blink electromygraphic recordings of startle reactivity while study participants view cannabis-related picture cues


Enrollment: 64
Study Start Date: December 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topiramate
Topiramate (200 mg daily)
Drug: Topiramate
Topiramate (200 mg daily)
Other Name: Topamax
Placebo Comparator: Sugar pill Drug: Placebo
Placebo (daily)

  Eligibility

Ages Eligible for Study:   15 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110434

Locations
United States, Rhode Island
Brown University, Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Robert Miranda, Ph.D. Brown University
  More Information

No publications provided

Responsible Party: Robert Miranda, Associate Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT01110434     History of Changes
Other Study ID Numbers: R01DA26778
Study First Received: April 20, 2010
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 22, 2014