Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

NCT01110434 | Completed Phase 2 Results DMC

• 1 other identifier: R01DA026778
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cannabis Abuse; Cannabis Dependence

Outcome Measures

Primary Outcomes (1)

• Cannabis Use

  Frequency of Cannabis Use (Percent Use Days Per Week)

  Weeks 1-6

Secondary Outcomes (2)

• Quantity of Cannabis Use

  Weeks 1-6

• Amount of Cannabis Use Per Use Day

  Weeks 1-6

Study Arms (2)

Topiramate

EXPERIMENTAL

Topiramate (200 mg daily)

Drug: Topiramate

Sugar pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Topiramate DRUG

Topiramate (200 mg daily)

Also known as: Topamax

Topiramate

Placebo DRUG

Placebo (daily)

Sugar pill

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Brown University, Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

Location

Related Publications (2)

• 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.

  PMID: 34014688 DERIVED

• Treloar 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.

  PMID: 29672090 DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Dr. Robert Miranda
• Organization: Brown University

Robert_Miranda_Jr@brown.edu

401.863.6658

Study Officials

• Robert Miranda, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 26, 2010
• Study Start: December 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Locations

US (1)