Conditions:
The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence.
To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating cocaine abstinence.
Dates: May 2008 -
Study Status: Recruiting
Ages Eligible: 18 Years - 65 Years
Gender Eligible: Both
Inclusion Criteria:
- Inclusion criteria
- Male and female opioid-dependent patients between the ages of 18-65 will be
entered into the study. Females must not be pregnant as determined by pregnancy
screening, nor breast feeding, and must be using acceptable birth control
methods during study participation.
- Current opioid dependence as evidenced by documentation of prior treatment for
opioid dependence or signs of withdrawal, self-reported history of opioid
dependence for consecutive 12 month period and a positive urine for opiates.
- Subjects must fulfill DSM-IV criteria for opioid and cocaine dependence.
- Subjects must have a history of cocaine use, with a reported street cocaine use
of a minimum of 1/2 gram during the preceding 30 days. Additionally, laboratory
confirmation of recent cocaine use (positive urine for cocaine) within 2 weeks
prior to admission to the study is required.
- Subjects must be treatment-seekers for opioid and cocaine use.
Exclusion criteria
- Current DSM-IV diagnosis of other drug or alcohol dependence (other than opiates,
cocaine, or tobacco)
- History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest
pain, arrhythmia, hypertension.
- History of severe renal, endocrine or hepatic diseases.
- History of psychosis, schizophrenia, or bipolar type I.
- History of seizure disorder.
- Current use of over-the-counter or prescription psychoactive drugs (antidepressant,
anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
- Liver function tests (SGOT,SGPT) greater than 3 times normal.
- Current use of modafinil
- Current suicidality
- Pregnancy or breast-feeding;
- Medical contraindication to treatment with study medication (e.g. for modafinil,
history of heart disease, ischemic ECG changes, arrhythmia, hypertension).
- Women of child-bearing potential must agree to use other means of birth control and
to have a pregnancy test repeated at least once monthly.
- Known allergy to modafinil or methadone.
Sponsor:
First Received: February 6, 2009
Last Updated: January 6, 2010
Clinicaltrials.gov ID:
NCT00838981
Study HIC # 0705002636
Conditions:
Interventions: Drug: Modafinil;
Drug: Placebo or sugar pill
The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence.
To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating cocaine abstinence.
Dates: May 2008 -
Study Status: Recruiting
Ages Eligible: 18 Years - 65 Years
Gender Eligible: Both
Inclusion Criteria:
- Inclusion criteria
- Male and female opioid-dependent patients between the ages of 18-65 will be
entered into the study. Females must not be pregnant as determined by pregnancy
screening, nor breast feeding, and must be using acceptable birth control
methods during study participation.
- Current opioid dependence as evidenced by documentation of prior treatment for
opioid dependence or signs of withdrawal, self-reported history of opioid
dependence for consecutive 12 month period and a positive urine for opiates.
- Subjects must fulfill DSM-IV criteria for opioid and cocaine dependence.
- Subjects must have a history of cocaine use, with a reported street cocaine use
of a minimum of 1/2 gram during the preceding 30 days. Additionally, laboratory
confirmation of recent cocaine use (positive urine for cocaine) within 2 weeks
prior to admission to the study is required.
- Subjects must be treatment-seekers for opioid and cocaine use.
Exclusion criteria
- Current DSM-IV diagnosis of other drug or alcohol dependence (other than opiates,
cocaine, or tobacco)
- History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest
pain, arrhythmia, hypertension.
- History of severe renal, endocrine or hepatic diseases.
- History of psychosis, schizophrenia, or bipolar type I.
- History of seizure disorder.
- Current use of over-the-counter or prescription psychoactive drugs (antidepressant,
anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
- Liver function tests (SGOT,SGPT) greater than 3 times normal.
- Current use of modafinil
- Current suicidality
- Pregnancy or breast-feeding;
- Medical contraindication to treatment with study medication (e.g. for modafinil,
history of heart disease, ischemic ECG changes, arrhythmia, hypertension).
- Women of child-bearing potential must agree to use other means of birth control and
to have a pregnancy test repeated at least once monthly.
- Known allergy to modafinil or methadone.
Sponsor:
First Received: February 6, 2009
Last Updated: January 6, 2010
Clinicaltrials.gov ID:
NCT00838981
Study HIC # 0705002636
James Poling, Ph.D.
Principal Investigator
HIC # 0805003779
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