Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Pennsylvania
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00142818

Purpose

Modafinil is a medication that may enhance mood and increase energy in cocaine addicts, which may be useful in preventing cocaine relapse. Naltrexone is a medication that is currently used to treat drug and alcohol addiction. A combination of these two medications may be beneficial in reducing drug and alcohol use in individuals undergoing substance abuse treatment. The purpose of this study is to evaluate the effectiveness of modafinil and naltrexone, alone and in combination, at reducing drug and alcohol use in individuals addicted to cocaine and alcohol.

Condition	Intervention	Phase
Alcohol-Related Disorders Alcoholism Cocaine-Related Disorders	Drug: Naltrexone Drug: Modafinil Drug: Placebo	Phase II

MedlinePlus related topics: Alcohol Consumption Alcoholism Urine and Urination

Drug Information available for: Modafinil Naltrexone 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Naltrexone hydrochloride Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Double-Blind, Placebo-Controlled, Pilot Trial of the Combination of Modafinil and Naltrexone for the Treatment of Cocaine and Alcohol Dependence

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

Primary Outcome Measures:

Cocaine use (measured by Timeline Follow Back and urine screen at Week 14 and the 6-month evaluation) [ Time Frame: 4+13 weeks ] [ Designated as safety issue: No ]
Number of days of abstinence from drinking and number of days of clinically significant drinking (measured by Timeline Follow Back at Week 14 and the 6-month evaluation) [ Time Frame: 4+13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Naltrexone-treated subjects will demonstrate a significantly greater reduction in cocaine use measured by the number of BE-negative urine samples and significantly reduced alcohol use measured by fewer days of clinically significant drinking. [ Time Frame: 4+13 weeks ] [ Designated as safety issue: No ]
Modafinil-treated subjects will demonstrate a significantly greater reduction in cocaine use measured by the number of BE-negative urine samples and significantly reduced alcohol use measured by fewer days of clinically significant drinking. [ Time Frame: 4+13 weeks ] [ Designated as safety issue: No ]
Naltrexone/modafinil-treated subjects will have fewer days of cocaine use, more abstinent days from alcohol, and fewer heavy drinking days during the follow up period compared to placebo-treated subjects. [ Time Frame: 4+13 weeks ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Experimental Nal + Mod	Drug: Naltrexone 150 mg daily for males; 100 mg daily for females Drug: Modafinil 400 mg daily
2: Experimental Nal	Drug: Naltrexone 150 mg daily for males; 100 mg daily for females
3: Experimental Mod	Drug: Modafinil 400 mg daily
4: Placebo Comparator Placebo	Drug: Placebo 400 mg and/or 100-150 mg placebo pills

Detailed Description:

Cocaine and alcohol addiction are serious health problems with no available medical treatment for preventing relapse. Past research has shown that individuals who are addicted to both cocaine and alcohol typically respond poorly to conventional substance abuse treatment. Little attention has been directed towards how best to treat these individuals. Naltrexone is a medication that is currently used to treat drug and alcohol addiction. It acts by blocking the "high" feeling produced by drugs and alcohol. Modafinil, another medication, enhances mood, increases energy, and improves concentration in people with narcolepsy. Preliminary research has shown that it may produce similar effects to cocaine, thereby potentially countering the symptoms of cocaine withdrawal. Cognitive Behavioral Coping Skills Therapy (CBT), a form of therapy that aims to alter an individual's patterns of behavior and drug use, is also an important component of substance abuse treatment. The purpose of this study is to compare the effectiveness of CBT plus placebo, CBT plus modafinil, CBT plus naltrexone, and CBT plus a combination of modafinil and naltrexone at reducing cocaine and alcohol use in individuals addicted to both substances.

This 14-week study will enroll individuals addicted to both cocaine and alcohol. During a 1-week screening period, potential participants will be required to complete a detoxification program, including stopping all cocaine and alcohol use. Participants will also undergo a physical exam and an electrocardiogram. Blood will be drawn for laboratory tests, and urine tests will be used to screen for the presence of drugs and alcohol. Individuals who complete the screening and meet all study requirements will be permitted to participate in the treatment phase of the study. During the 13-week treatment phase, participants will be randomly assigned to receive modafinil, naltrexone, a combination of modafinil and naltrexone, or placebo. All participants will attend a CBT session once a week. Study visits will take place twice a week. At each visit, a urine test and breathalyzer will be used to screen for the presence of alcohol and drugs. Participants will also complete standardized psychological questionnaires to measure drug and alcohol craving, treatment services received, severity of illness, and withdrawal symptoms. In addition, participants will meet weekly with a nurse practitioner, who will dispense study medications, monitor adverse events, and evaluate the participant's clinical status. A follow-up evaluation will occur 6 months following the end of treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets DSM-IV diagnostic criteria for cocaine and alcohol dependence, as determined by the Structured Clinical Interview (SCID)
Has used no less than $200 worth of cocaine in the 30 days prior to study entry
Has used alcohol within 30 days of study entry, as measured by the Timeline Follow Back
Has consumed a minimum of 48 standard alcoholic drinks (average of 12 drinks per week) in a consecutive 30-day period over the 90-day period prior to study entry (i.e., a minimum of 40% days drinking), as measured by the Timeline Follow Back
Has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in a consecutive 30-day period over the 90-day period prior to study entry, as measured by the Timeline Follow Back
Has 5 consecutive days of abstinence from cocaine and alcohol, as determined by self-report and confirmed by a negative urine screen, a negative breathalyzer test, a collateral report, and a score of less than 8 on the Clinical Institute Withdrawal Scale for Alcohol
Lives within commuting distance of the treatment research clinic
Agrees to attend all research visits, including follow-up visits
Speaks, understands, and writes English
If female, willing to use a non-oral form of contraception throughout the study

Exclusion Criteria:

Meets DSM-IV diagnostic criteria for dependence on any substance other than cocaine, alcohol, or nicotine, as determined by the SCID
Has abstained from cocaine or alcohol for 30 consecutive days prior to study entry
Has a positive urine drug screen for any drug other than cocaine in the week prior to study entry (one repeat test is permitted)
Meets DSM-IV diagnostic criteria for any of the following current Axis I disorders: panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or eating disorders
Meets current or lifetime DSM-IV diagnostic criteria for schizophrenia, any psychotic disorder, or organic mental disorder
History of significant blood, lung, endocrine, heart, kidney, or gastrointestinal disease (including a history of heart attack, mitral valve prolapse, left ventricular hypertrophy, or uncontrolled hypertension)
Severe medical illness, such as AIDS, active hepatitis, significant hepatocellular injury with either elevated total bilirubin levels greater than 1.3 mg/dl or elevated aspartate aminotransferase (AST) and serum glutamic-pyruvic transaminase (SGPT) levels at least 3.5 times above normal, after the required 3 days of abstinence
History of hypersensitivity to modafinil or naltrexone
Currently using any psychoactive medications, including any anti-seizure medications (with the exception of diphenhydramine if used sparingly for sleep disturbance)
Receiving chronic therapy with any drug known to interact adversely with either modafinil or naltrexone, including propranolol, phenytoin, warfarin, or diazepam
Has taken a monoamine oxidase inhibitor within the 30 days prior to study entry
Has taken an investigational drug within the 60 days prior to study entry
Has taken any opiate substitute (methadone, LAAM, buprenorphine) within the 60 days prior to study entry
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142818

Contacts

Contact: Donna Simpson

215-243-9959

Locations

United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104 6178
Contact: Kristi Varillo, MS 215-222-3200 varillo_k@mail.trc.upenn.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Pennsylvania

Investigators

Principal Investigator:

Helen M. Pettinati, PhD

University of Pennsylvania

More Information

Responsible Party:	University of Pennsylvania Treatment Research Cener ( Kyle M. Kampman M.D. )
Study ID Numbers:	NIDA-12756-3, P50-12756-3, DPMC
Study First Received:	September 1, 2005
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00142818
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):

Alcohol Abuse
Cocaine Abuse

Study placed in the following topic categories:

Cocaine-Related Disorders
Dopamine
Mental Disorders
Naltrexone
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Alcohol-Related Disorders
Cocaine
Modafinil
Ethanol

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Central Nervous System Stimulants
Cardiovascular Agents

Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Anesthetics, Local
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009