Medications for Stopping Cocaine Dependence and Preventing Relapse - Full Text View

Sponsor:	University of Texas
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218023

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 identify subpopulations and baseline conditions that are most responsive to treatment for cocaine dependent individuals.

Condition	Intervention	Phase
Cocaine Abuse Cocaine-Related Disorders	Drug: Naltrexone Drug: Modafinil Drug: Levodopa/Carbidopa 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:	Screening Medications for Cocaine Cessation and Relapse Prevention

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Levodopa Naltrexone Naltrexone hydrochloride Carbidopa Modafinil

U.S. FDA Resources

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

Primary Outcome Measures:

Confirmed abstinence from cocaine [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Naltrexone hydrochloride , 50mg per day	Drug: Naltrexone Naltrexone hydrochloride 50mg per day, A 2-day dose run up procedure starting at 25mg and increasing by 25 mg will be followed by a fixed daily dose administered as 25 mg bid. Subjects will be instructed to take one pill by mouth twice a day and to continue to do so throughout the 12-week treatment phase of the study.
2: Experimental Levodopa/carbidopa, 800/200 mg per day	Drug: Levodopa/Carbidopa Levodopa/carbidopa, 800/200 mg per day, in the sustained release formulation (Sinemet CR) will be the pharmacotherapy in this condition. A 2-day dose run up procedure starting at 400mg l-dopa and 100 mg carbidopa per day will be followed by a fixed daily dose administered as 400/100 bid
3: Experimental Modafinil 200mg	Drug: Modafinil A 2-day dose run up procedure starting at 200 mg modafinil per day will be followed by a fixed daily dose administered as 400 mg/day.
4: Placebo Comparator	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. Motivational Interviewing (MI) is often effective when combined with drug treatment. Baseline condition (e.g., abstinence status) and population type (e.g., ethnicity and gender) often affect how an individual responds to treatment for drug dependence. The purpose of this study is to determine the influence of baseline status and population type on treatment response in cocaine dependent individuals. In addition, this study will examine how various cocaine abuse medications target different neuronal systems, withdrawal symptoms, and relapse to drug use.

This study will take place in two phases. Phase I will last 4 weeks; participants will receive MI and undergo contingency-based urine tests in order to achieve the desired baseline condition. Phase II will last 12 weeks. Participants in Phase II will be randomly assigned to receive one of four treatments: 1) 50 mg naltrexone, 2) 800/200 mg levodopa/carbidopa, 3) 400 mg modafinil, or 4) placebo. During Phase II, all participants will receive psychotherapy and contingency management. Participants will complete urine drug screening tests 3 times each week. Follow-up study visits will occur between 3 and 6 months following Week 12, and will include objective and self-reported drug use.

Eligibility

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

Criteria

Inclusion Criteria:

Meets DSM-IV criteria for current cocaine dependence

Exclusion Criteria:

Meet diagnostic criteria for other serious psychiatric symptoms and/or disorders that would interfere with participation in the treatment study (e.g., psychosis; mania; suicidal/ homicidal ideation) including other forms of drug dependence, nicotine and cannabis excepted.
Medical conditions contraindicating naltrexone therapy (e.g., past history of opioid use in the 30 days prior to study entry or significant hepatocellular injury)
Medical conditions contraindicating modafinil therapy (e.g., hypertension, seizures, arrhythmia, or coronary artery disease)
Medical conditions contraindicating levodopa/carbidopa therapy (e.g., severe pulmonary/cardiovascular disease, narrow angle glaucoma, melanoma, history of peptic ulcer, or renal function impairment)
Requires certain medications
Current or recent treatment for substance use or other psychiatric condition
On parole or probation that requires reports of drug use to officers of the court
Pending incarceration
Pregnant or breastfeeding
Unable to read, write, or speak English
Plans to leave the study area within 3 months of study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218023

Contacts

Contact: Laura B Madden-Fuentes, B.A.	713-500-2563	Laura.MaddenFuentes@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

University of Texas

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Joy Schmitz, PhD

University of Texas

More Information

Additional Information:

Click here for more information about the University of Texas Treatment Research Clinic 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-09262-7, P50DA009262-07, DPMC
Study First Received:	September 16, 2005
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00218023 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cocaine-Related Disorders
Neurotransmitter Agents
Levodopa
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Narcotic Antagonists
Physiological Effects of Drugs
Carbidopa
Disorders of Environmental Origin
Antiparkinson Agents
Central Nervous System Stimulants
Enzyme Inhibitors

Protective Agents
Neuroprotective Agents
Modafinil
Pharmacologic Actions
Sensory System Agents
Mental Disorders
Therapeutic Uses
Naltrexone
Substance-Related Disorders
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 04, 2010