Topiramate for the Treatment of Methamphetamine Dependence - 1

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00345371
• Collaborator: (none)
• Enrollment: 140
• Locations: 8
• Arms: 2
• Duration (Months): 32
• Patients Per Site: 17.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine	Drug: Topiramate; Drug: Placebo Oral Tablet	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase 2, Double-Blind, Placebo-Controlled Trial of Topiramate for the Treatment of Methamphetamine Dependence
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Topiramate Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.	Drug: Topiramate; Other Names: Topamax
Placebo Comparator: Placebo Oral Tablet After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.	Drug: Placebo Oral Tablet

Outcome Measures

Primary Outcome Measures

1. Abstinence (Weeks 6 - 12) [weeks 6 through 12]

   The number of participants who abstained from methamphetamine from weeks 6 through 12

Secondary Outcome Measures

1. Abstinence (Weeks 1 - 12) [Weeks 1 through 12]

   Number of participants who abstained from methamphetamine from weeks 1 through 12

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Treatment seeking individuals as the time of the study

• Must be able to proved written informed consent

• Must have a body mass index greater than 18 kg/m(2)

• Must meet DSM-IV criteria for methamphetamine dependence

• Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days

• If female of child bearing potential, must agree to use birth control

Exclusion Criteria:

• Please contact the site for more information

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Matrix Institute on Addictions	Costa Mesa	California	United States	92627
2	South Bay Treatment Center	San Diego	California	United States	92105
3	Torrance Site	Torrance	California	United States	90502
4	John A. Burns School of Medicine	Honolulu	Hawaii	United States	96813
5	Powell Chemical Dependency Center	Des Moines	Iowa	United States	50316
6	University of Missouri - Kansas City	Kansas City	Missouri	United States	64108
7	Salt Lake City VA Medical Center	Salt Lake City	Utah	United States	84148
8	UVA CARE	Charlottesville	Virginia	United States	22911

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Bankole Johnson, VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to abstract

Publications

• Elkashef A, Kahn R, Yu E, Iturriaga E, Li SH, Anderson A, Chiang N, Ait-Daoud N, Weiss D, McSherry F, Serpi T, Rawson R, Hrymoc M, Weis D, McCann M, Pham T, Stock C, Dickinson R, Campbell J, Gorodetzky C, Haning W, Carlton B, Mawhinney J, Li MD, Johnson BA. Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial. Addiction. 2012 Jul;107(7):1297-306. doi: 10.1111/j.1360-0443.2011.03771.x. Epub 2012 Feb 28. Erratum in: Addiction. 2012 Sep;107(9):1718. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.

• Responsible Party: National Institute on Drug Abuse (NIDA)
• ClinicalTrials.gov Identifier: NCT00345371
• Other Study ID Numbers: NIDA-CSP-1025-1; NCT00431652
• First Posted: Jun 28, 2006
• Last Update Posted: Mar 27, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by National Institute on Drug Abuse (NIDA): methamphetamine addiction
• Additional relevant MeSH terms: Topiramate

Study Results

Participant Flow

Arm/Group Title	Topiramate	Placebo Oral Tablet
Arm/Group Description	Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. Topiramate	After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. Placebo Oral Tablet
Period Title: Overall Study
STARTED	69	71
COMPLETED	39	38
NOT COMPLETED	30	33

Baseline Characteristics

Arm/Group Title	Topiramate	Placebo Oral Tablet	Total
Arm/Group Description	Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. Topiramate	After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. Placebo Oral Tablet	Total of all reporting groups
Overall Participants	69	71	140
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.4 (8.83)	37.5 (8.47)	38 (8.62)
Sex: Female, Male (Count of Participants)
Female	28 40.6%	23 32.4%	51 36.4%
Male	41 59.4%	48 67.6%	89 63.6%
Region of Enrollment (participants) [Number]
United States	69 100%	71 100%	140 100%

Outcome Measures

1. Primary Outcome

Title	Abstinence (Weeks 6 - 12)
Description	The number of participants who abstained from methamphetamine from weeks 6 through 12
Time Frame	weeks 6 through 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Placebo Oral Tablet
Arm/Group Description	Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. Topiramate	After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. Placebo Oral Tablet
Measure Participants	69	71
Week 6	49 71%	49 69%
Week 7	43 62.3%	48 67.6%
Week 8	46 66.7%	45 63.4%
Week 9	40 58%	41 57.7%
Week 10	38 55.1%	33 46.5%
Week 11	36 52.2%	38 53.5%
Week 12	34 49.3%	32 45.1%

2. Secondary Outcome

Title	Abstinence (Weeks 1 - 12)
Description	Number of participants who abstained from methamphetamine from weeks 1 through 12
Time Frame	Weeks 1 through 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topiramate	Placebo Oral Tablet
Arm/Group Description	Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. Topiramate	After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. Placebo Oral Tablet
Measure Participants	69	71
Week 1	58 84.1%	53 74.6%
Week 2	56 81.2%	50 70.4%
Week 3	55 79.7%	50 70.4%
Week 4	55 79.7%	50 70.4%
Week 5	56 81.2%	51 71.8%
Week 6	49 71%	49 69%
Week 7	43 62.3%	48 67.6%
Week 8	46 66.7%	45 63.4%
Week 9	40 58%	41 57.7%
Week 10	38 55.1%	33 46.5%
Week 11	36 52.2%	38 53.5%
Week 12	34 49.3%	32 45.1%

Adverse Events

Arm/Group Title	Topiramate		Placebo Oral Tablet
Arm/Group Description	Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. Topiramate		After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. Placebo Oral Tablet
All Cause Mortality
	Topiramate		Placebo Oral Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Topiramate		Placebo Oral Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/69 (4.3%)		8/71 (11.3%)
Blood and lymphatic system disorders
Anemia	1/69 (1.4%)	1	0/71 (0%)	0
Cardiac disorders
Malignant hypertention (with angina)	0/69 (0%)	0	1/71 (1.4%)	1
Abnormal ECG	0/69 (0%)	0	1/71 (1.4%)	1
Eye disorders
Visual Disturbance	0/69 (0%)	0	1/71 (1.4%)	1
Infections and infestations
Diverticulitis	1/69 (1.4%)	2	0/71 (0%)	0
Infected Boil	1/69 (1.4%)	1	0/71 (0%)	0
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/69 (0%)	0	1/71 (1.4%)	1
Psychiatric disorders
Superficial Cutting	0/69 (0%)	0	1/71 (1.4%)	1
Disorientation	0/69 (0%)	0	1/71 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Shortness of Breath	0/69 (0%)	0	1/71 (1.4%)	1
Social circumstances
Assault	0/69 (0%)	0	1/71 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Topiramate		Placebo Oral Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	63/69 (91.3%)		64/71 (90.1%)
Gastrointestinal disorders
Diarrhea	11/69 (15.9%)	14	8/71 (11.3%)	12
General disorders
Fatigue	20/69 (29%)	22	14/71 (19.7%)	17
Nervous system disorders
Headache	33/69 (47.8%)	76	30/71 (42.3%)	68
Dizziness	9/69 (13%)	10	5/71 (7%)	8
Respiratory, thoracic and mediastinal disorders
Cough	16/69 (23.2%)	18	11/71 (15.5%)	14

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.