Effectiveness of Modafinil and D-Amphetamine in Treating Cocaine Dependent Individuals - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Texas
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218062

Purpose

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Dextro amphetamine sulfate and Modafinil Drug: modafinil Drug: Modafinil 400 mg Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Dextroamphetamine sulfate Dextroamphetamine Amphetamine sulfate Modafinil Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Substance use [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Medication compliance [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
medication side effects [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2006
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental Modafinil 200mg	Drug: modafinil 10 day medication run-up of modafinil from 0-200mg
3: Experimental Modafinil 400mg	Drug: Modafinil 400 mg 10 day run up to 400mg of modafinil
1: Experimental Modafinil 200mg/ D-Amphetamine 30mg	Drug: Dextro amphetamine sulfate and Modafinil d-amphetamine 30mg / modafinil 200mg
Placebo: Placebo Comparator Placebo	Drug: Placebo Placebo

Detailed Description:

Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine dependence. The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine, alone and in combination, in treating cocaine dependent individuals.

This study will last 16 weeks. Participants will be randomly assigned to one of four groups: 1) 200 mg dose of modafinil; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg of modafinil over 4 days.

Participants assigned to the 400 mg modafinil treatment group will then receive double the initial dose of modafinil for the duration of the study.

Participants in the combined group (modafinil and d-amphetamine) will receive 15 and then 30 mg of d-amphetamine over 4 days.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Meets SCID criteria for cocaine abuse or dependence
In general good health. Individuals who are HIV-positive will not be excluded if in good general health, unless medication interactions exist.

Exclusion Criteria:

Meets diagnostic criteria for psychiatric disorders, including other forms of drug dependence, other than nicotine
Current cardiovascular disease, as determined by an electrocardiogram
On probation or parole if the circumstances do not allow study completion or if ethical constraints of supervision do not allow confidentiality
Previously received treatment with d-amphetamine, modafinil, or aripiprazole
Currently receiving prescribed medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218062

Contacts

Contact: Jan Lindsay, Ph.D.	713-500-2563	jan.a.lindsay@uth.tmc.edu
Contact: Ann Garcia, MA	713-500-2804	Ann.D.Garcia@uth.tmc.edu

Locations

United States, Texas
University of Texas Health Science Center	Recruiting
Houston, Texas, United States, 77030
Contact: Ann Garcia, MA 713-500-2804 Ann.D.Garcia@uth.tmc.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Texas

Investigators

Principal Investigator:

Joy M. Schmitz, PhD

University of Texas

More Information

Additional Information:

Click here for more information about the Treatment Research Clinic at the University of Texas Health Center at Houston This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Texas Medical School at Houston ( Joy Schmitz, Ph.D. )
Study ID Numbers:	NIDA-09262-12, P50-DA009262-12, DPMC
Study First Received:	September 16, 2005
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00218062 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Cocaine-Related Disorders
Neurotransmitter Agents
Adrenergic Agents
Disorders of Environmental Origin
Central Nervous System Stimulants
Neuroprotective Agents
Modafinil
Methamphetamine

Dopamine
Mental Disorders
Dextroamphetamine
Substance-Related Disorders
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Cocaine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Disorders of Environmental Origin
Neuroprotective Agents
Modafinil
Mental Disorders
Therapeutic Uses
Substance-Related Disorders

Cocaine-Related Disorders
Sympathomimetics
Central Nervous System Stimulants
Protective Agents
Pharmacologic Actions
Methamphetamine
Autonomic Agents
Dextroamphetamine
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009