- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00142818
Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence (Mod-Nal)
A Phase II, Double-blind, Placebo-Controlled, Pilot Trial of the Combination of Modafinil and Naltrexone for the Treatment of Cocaine and Alcohol Dependence
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104 6178
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
4.1 Inclusion Criteria
- Male and females, 18 years of age or older.
- Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID-IV.
In the past 30 days, used no less than $200-worth of cocaine and meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell, 1995):
- drank within 30 days of intake day,
- reports a minimum of 48 standard alcoholic (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and
- 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 this same pre-treatment period.
- 72 consecutive hours of abstinence from alcohol, determined by self-reports and confirmed by a negative breathalyzer tests, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan, 1989) score below eight. Subjects will be encouraged to achieve 72 consecutive hours of abstinence, however, subjects who have achieved between 48 and 72 consecutive hours of abstinence will be included with the approval of the principal investigator. We anticipate that these subjects will comprise less than 5% of total enrolled subjects. Subjects will be given 2 additional weeks beyond the screening week to attain the appropriate period of alcohol abstinence prior to randomization.
- Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
- Speaks, understands, and prints in English
- Ability to give informed consent
Exclusion Criteria
- Abstinent from cocaine or alcohol for 30 consecutive days prior to signing consent form.
- Meets DSM IV criteria for dependence on any substance other than cocaine and alcohol (except nicotine), determined by the SCID.
- Needs treatment with any psychoactive medications including any anti-seizure medications (with the exception of diphenhydramine used sparingly, if necessary, for sleep).
- Meets current or lifetime DSM-IV criteria for schizophrenia or any psychotic disorder or organic mental disorder. Subject meets current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation.
- Has evidence of a history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease (including a history of myocardial infarction, mitral valve prolapse, left ventricular hypertrophy, uncontrolled hypertension).
- Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated total bilirubin levels (>1.3 mg/dl),or elevated levels (over 4.5x normal) of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT) after the required 3 days of abstinence.
- Use of an investigational medication in the 30 days prior to randomization.
- History of hypersensitivity to modafinil or naltrexone
- Receiving chronic therapy with any drug known to interact adversely with either modafinil or naltrexone including propranolol, phenytoin, warfarin, diazepam
- Took a monoamine oxidase inhibitor within 30 days of randomization.
- Is female and tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant). Acceptable methods of contraception include barrier methods (diaphragm or condom with spermicide, female condom), intrauterine progesterone contraceptive system, levonorgrestrel implant, and medroxyprogeterone acetate contraceptive injection, copper IUD, vaginal contraceptive film, cervical cap, contraceptive foam.
- Current use of an oral contraceptive without other acceptable barrier method of contraception.
- Received therapy with any opiate substitute (methadone, LAAM, buprenorphine) within 60 days of randomization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
400 mg and/or 100-150 mg placebo pills
|
Experimental: Naltrexone plus modafinil
Nal + Mod
|
150 mg daily for males; 100 mg daily for females
Other Names:
400 mg daily
Other Names:
|
Experimental: Naltrexone
Nal
|
150 mg daily for males; 100 mg daily for females
Other Names:
|
Experimental: Modafinil
Mod
|
400 mg daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14)
Time Frame: 13 weeks
|
13 weeks
|
Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14
Time Frame: 13 weeks
|
13 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kyle M. Kampman, M.D., University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Substance-Related Disorders
- Alcoholism
- Disease
- Alcohol-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Alcohol Deterrents
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Naltrexone
- Modafinil
Other Study ID Numbers
- NIDA-12756-3
- DPMC (Other Identifier: NIDA)
- P50DA012756-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcoholism
-
Yale UniversityCompletedFamilial Alcoholism VulnerabilityUnited States
-
Yonsei UniversityTerminated
-
Yale UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingFamilial Alcoholism VulnerabilityUnited States
-
University of Southern DenmarkActive, not recruitingGeneral Practice | Alcohol Abuse Alcoholism | Screening and Brief InterventionDenmark
-
University of FloridaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedEffects of Family History of Alcoholism and Sex on Alcohol AnalgesiaUnited States
-
Brown UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcoholic Liver Disease | Alcoholism,United States
-
Khoo Teck Puat HospitalNot yet recruitingEmergencies | Alcohol Use Disorder | Alcoholism and Alcohol Abuse
-
National Institute on Drug Abuse (NIDA)The Peter G. Dodge Foundation (PGDF)Completed
-
Virginia Commonwealth UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Yale University; University...CompletedAlcoholismUnited States
-
University of Sao PauloCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... and other collaboratorsEnrolling by invitation
Clinical Trials on Naltrexone
-
San Diego State UniversityRecruitingPlacebo | NaltrexoneUnited States
-
Yale UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcohol Dependence | Human Immunodeficiency Virus | AIDS | Hazardous Drinking | Problem DrinkingUnited States
-
Alkermes, Inc.Terminated
-
Alkermes, Inc.Completed
-
Alkermes, Inc.Completed
-
University of PennsylvaniaNational Institute on Drug Abuse (NIDA); St. Petersburg State Pavlov Medical...CompletedOpioid-Related Disorders | Heroin DependenceUnited States, Russian Federation
-
Medical University of LublinRecruitingQuality of Life | Vulvodynia | NaltrexonePoland
-
Centre for Addiction and Mental HealthUnknown
-
Drug Delivery Company, LLC DBA Akyso PharmaceuticalsNational Institute on Drug Abuse (NIDA); Laboratory Corporation of America; Cognitive...Not yet recruiting
-
State University of New York - Upstate Medical...CephalonCompletedAlcohol Dependence | Schizophrenia | Schizoaffective Disorders | Bipolar DisordersUnited States