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Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence (Mod-Nal)

Primary Purpose

Alcohol-Related Disorders, Alcoholism, Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Modafinil
Placebo
Sponsored by
Kyle Kampman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol-Related Disorders focused on measuring Alcohol Abuse, Cocaine Abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Naltrexone plus modafinil

Naltrexone

Modafinil

Placebo

Arm Description

Nal + Mod

Nal

Mod

Placebo

Outcomes

Primary Outcome Measures

Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14)
Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
July 14, 2020
Sponsor
Kyle Kampman
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00142818
Brief Title
Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence
Acronym
Mod-Nal
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kyle Kampman
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders, Alcoholism, Cocaine-Related Disorders
Keywords
Alcohol Abuse, Cocaine Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone plus modafinil
Arm Type
Experimental
Arm Description
Nal + Mod
Arm Title
Naltrexone
Arm Type
Experimental
Arm Description
Nal
Arm Title
Modafinil
Arm Type
Experimental
Arm Description
Mod
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
ReVia
Intervention Description
150 mg daily for males; 100 mg daily for females
Intervention Type
Drug
Intervention Name(s)
Modafinil
Other Intervention Name(s)
Provigil
Intervention Description
400 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
400 mg and/or 100-150 mg placebo pills
Primary Outcome Measure Information:
Title
Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14)
Time Frame
13 weeks
Title
Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle M. Kampman, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104 6178
Country
United States

12. IPD Sharing Statement

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Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence

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