Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Brown University

Status and phase

Completed

Phase 2

Conditions

Cannabis Dependence

Cannabis Abuse

Treatments

Drug: Placebo

Drug: Topiramate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01110434

R01DA026778 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

15 to 20 years old

Volunteers

Accepts Healthy Volunteers

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