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Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Information source: Brown University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cannabis Abuse; Cannabis Dependence

Intervention: Topiramate (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Brown University

Official(s) and/or principal investigator(s):
Robert Miranda, Ph.D., Principal Investigator, Affiliation: Brown University

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. 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.

Clinical Details

Official title: Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Cannabis Use

Secondary outcome: Surface Eye Blink Electromyography (EMG)

Eligibility

Minimum age: 15 Years. Maximum age: 20 Years. Gender(s): Both.

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

Locations and Contacts

Brown University, Center for Alcohol and Addiction Studies, Providence, Rhode Island 02912, United States
Additional Information

Starting date: December 2009
Last updated: July 11, 2012

Page last updated: August 23, 2015

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