Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

• Sponsor: Brown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01110434
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Abuse; Cannabis Dependence	Drug: Topiramate; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topiramate Topiramate (200 mg daily)	Drug: Topiramate; Topiramate (200 mg daily); Other Names: Topamax
Placebo Comparator: Sugar pill	Drug: Placebo; Placebo (daily)

Outcome Measures

Primary Outcome Measures

1. Cannabis Use [Weeks 1-6]

   Frequency of Cannabis Use (Percent Use Days Per Week)

Secondary Outcome Measures

1. Quantity of Cannabis Use [Weeks 1-6]

   Total Grams of Cannabis Use Per week

2. Amount of Cannabis Use Per Use Day [Weeks 1-6]

   Average Grams of Cannabis Used Per Use Day

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Brown University, Center for Alcohol and Addiction Studies	Providence	Rhode Island	United States	02912

Sponsors and Collaborators

• Brown University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Robert Miranda, Ph.D., Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Miranda, Associate Professor (Research), Brown University
• ClinicalTrials.gov Identifier: NCT01110434
• Other Study ID Numbers: R01DA026778; R01DA026778
• First Posted: Apr 26, 2010
• Last Update Posted: Sep 16, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Marijuana Abuse; Topiramate

Study Results

Participant Flow

Arm/Group Title	Topiramate	Sugar Pill
Arm/Group Description	Topiramate (200 mg daily) Topiramate: Topiramate (200 mg daily)	Placebo: Placebo (daily)
Period Title: Overall Study
STARTED	40	26
COMPLETED	29	20
NOT COMPLETED	11	6

Baseline Characteristics

Arm/Group Title	Topiramate	Sugar Pill	Total
Arm/Group Description	Topiramate (200 mg daily) Topiramate: Topiramate (200 mg daily)	Placebo: Placebo (daily)	Total of all reporting groups
Overall Participants	40	26	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.30 (2.03)	18.81 (2.08)	19.71 (2.16)
Sex: Female, Male (Count of Participants)
Female	20 50%	12 46.2%	32 48.5%
Male	20 50%	14 53.8%	34 51.5%

Outcome Measures

1. Primary Outcome

Title	Cannabis Use
Description	Frequency of Cannabis Use (Percent Use Days Per Week)
Time Frame	Weeks 1-6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Sugar Pill
Arm/Group Description	Topiramate (200 mg daily) Topiramate: Topiramate (200 mg daily)	Placebo: Placebo (daily)
Measure Participants	40	26
Mean (Standard Deviation) [Percentage of use days]	55.89 (32.35)	63.10 (34.91)

2. Secondary Outcome

Title	Quantity of Cannabis Use
Description	Total Grams of Cannabis Use Per week
Time Frame	Weeks 1-6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Sugar Pill
Arm/Group Description	Topiramate (200 mg daily) Topiramate: Topiramate (200 mg daily)	Placebo: Placebo (daily)
Measure Participants	40	26
Mean (Standard Deviation) [Grams Per Week]	1.87 (2.11)	2.85 (3.29)

3. Secondary Outcome

Title	Amount of Cannabis Use Per Use Day
Description	Average Grams of Cannabis Used Per Use Day
Time Frame	Weeks 1-6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Sugar Pill
Arm/Group Description	Topiramate (200 mg daily) Topiramate: Topiramate (200 mg daily)	Placebo: Placebo (daily)
Measure Participants	40	26
Mean (Standard Deviation) [Average Grams Per Use Day]	0.46 (0.32)	0.60 (0.48)

Adverse Events

Time Frame	Data were collected during the 6-week medication (or placebo pill) period.
Adverse Event Reporting Description	We followed the same definition as clinicaltrials.gov.
Arm/Group Title	Topiramate		Sugar Pill
Arm/Group Description	Topiramate (200 mg daily) Topiramate: Topiramate (200 mg daily)		Placebo: Placebo (daily)
All Cause Mortality
	Topiramate		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/26 (0%)
Serious Adverse Events
	Topiramate		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Topiramate		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/40 (87.5%)		24/26 (92.3%)
Eye disorders
Changes in Vision	4/40 (10%)		0/26 (0%)
Gastrointestinal disorders
Stomach Pain, Cramps	2/40 (5%)		3/26 (11.5%)
Nausea	12/40 (30%)		8/26 (30.8%)
General disorders
Headache	8/40 (20%)		6/26 (23.1%)
Cough, Cold Symptoms	5/40 (12.5%)		5/26 (19.2%)
Injury	8/40 (20%)		5/26 (19.2%)
Parasthesias	15/40 (37.5%)		2/26 (7.7%)
Sore Throat	4/40 (10%)		2/26 (7.7%)
Runny Nose, Sinus Problems, Sneezing	14/40 (35%)		12/26 (46.2%)
Decrease in Appetite	19/40 (47.5%)		9/26 (34.6%)
Weight Loss	20/40 (50%)		6/26 (23.1%)
Difficulty with Coordination or Balance	6/40 (15%)		0/26 (0%)
Difficulty with Memory	8/40 (20%)		5/26 (19.2%)
Fatigue	9/40 (22.5%)		9/26 (34.6%)
Dizziness	10/40 (25%)		2/26 (7.7%)
Difficulty with Concentration or Attention	11/40 (27.5%)		2/26 (7.7%)
Word Finding Difficulties	11/40 (27.5%)		4/26 (15.4%)
Slow Thinking or Reactions	12/40 (30%)		4/26 (15.4%)
Drowsiness or Sleepiness	12/40 (30%)		13/26 (50%)
Fever	0/40 (0%)		2/26 (7.7%)
Psychiatric disorders
Irritability	2/40 (5%)		3/26 (11.5%)
Nervousness	4/40 (10%)		0/26 (0%)
Confusion	5/40 (12.5%)		0/26 (0%)
Anxiety	10/40 (25%)		0/26 (0%)
Depression	10/40 (25%)		1/26 (3.8%)
Skin and subcutaneous tissue disorders
Rash	0/40 (0%)		3/26 (11.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.