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Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Primary Purpose

Cannabis Abuse, Cannabis Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topiramate
Placebo
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Abuse

Eligibility Criteria

15 Years - 20 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • Brown University, Center for Alcohol and Addiction Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topiramate

Sugar pill

Arm Description

Topiramate (200 mg daily)

Outcomes

Primary Outcome Measures

Cannabis Use
Frequency of Cannabis Use (Percent Use Days Per Week)

Secondary Outcome Measures

Quantity of Cannabis Use
Total Grams of Cannabis Use Per week
Amount of Cannabis Use Per Use Day
Average Grams of Cannabis Used Per Use Day

Full Information

First Posted
April 20, 2010
Last Updated
August 27, 2020
Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01110434
Brief Title
Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents
Official Title
Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Abuse, Cannabis Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topiramate
Arm Type
Experimental
Arm Description
Topiramate (200 mg daily)
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topamax
Intervention Description
Topiramate (200 mg daily)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (daily)
Primary Outcome Measure Information:
Title
Cannabis Use
Description
Frequency of Cannabis Use (Percent Use Days Per Week)
Time Frame
Weeks 1-6
Secondary Outcome Measure Information:
Title
Quantity of Cannabis Use
Description
Total Grams of Cannabis Use Per week
Time Frame
Weeks 1-6
Title
Amount of Cannabis Use Per Use Day
Description
Average Grams of Cannabis Used Per Use Day
Time Frame
Weeks 1-6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Miranda, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University, Center for Alcohol and Addiction Studies
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34014688
Citation
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.
Results Reference
derived
PubMed Identifier
29672090
Citation
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.
Results Reference
derived

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Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

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