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Modafinil vs Placebo for the Treatment of Methamphetamine Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steve Shoptaw, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00469508
First received: May 3, 2007
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

Modafinil is a non-amphetamine type stimulant that acts as a wakefulness-promoting drug, and is approved for managing symptoms of narcolepsy (i.e., daytime somnolence). Its precise mechanism of action in promoting wakefulness remains unclear. This trial is a placebo-controlled double-blind trial of modafinil, on a platform of contingency management (CM) and individual cognitive-behavioral (CBT) counseling, for the treatment of methamphetamine dependence. Participants in this study will complete a 2-week baseline screening period during which they will provide urine samples and complete physical and psychological assessments to establish their eligibility for the study. In addition, participants will be asked to provide a blood or saliva specimen for genetic testing in order to identify genetic variations that influence response to methamphetamine and to treatment with modafinil. Upon successful completion of screening, participants will be randomly assigned to receive either modafinil (400mg qd) or placebo during the 12 weeks of the study. Neither the participants nor study staff will know who is receiving active medication or placebo. Regardless of medication condition, all participants will receive CM and weekly individual CBT counseling sessions to help them stop using methamphetamine and prevent relapse. They will attend the clinical research site (either at the UCLA Hollywood Clinic, or the Rancho Cucamonga site) three times per week, providing urine samples at each visit, completing data measures, and receiving individual CBT counseling on one visit each week. At the end of the 12-week study, the medication or placebo will be discontinued. Participants will return to the research site approximately 30 days following medication discontinuation for a brief health check to assess any possible lingering side effects and complete brief data measures.


Condition Intervention Phase
Methamphetamine Dependence
Drug: Modafinil
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of Modafinil vs Placebo for the Treatment of Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Clean Urine Drug Screen [ Time Frame: From randomization to end of week 12 ] [ Designated as safety issue: No ]
    Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.


Secondary Outcome Measures:
  • Retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The number of persons who completed the medication phase of the trial (12 weeks of medication).


Other Outcome Measures:
  • VAS Score [ Time Frame: baseline and last observation during the 12 week treatment period ] [ Designated as safety issue: No ]
    To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12.

  • BDI Score [ Time Frame: From baseline to end of treatment period (week 12). ] [ Designated as safety issue: No ]
    Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression.


Enrollment: 71
Study Start Date: April 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Modafinil
Modafinil 400mg oral dose taken daily for 12 weeks
Drug: Modafinil
400mg pills taken orally daily for 12 wks.
Other Name: Provigil
Placebo Comparator: Placebo
Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Drug: Placebo
400mg pills taken orally daily for 12 wks
Other Name: Sugar pill

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 years of age or older;
  2. meet DSM-IV criteria for methamphetamine dependence;
  3. willing and able to comply with study procedures;
  4. willing and able to provide written informed consent;
  5. if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial and for one month after discontinuation of study medication (modafinil may reduce the effectiveness of steroidal contraceptives both during administration and for one month after discontinuation).

Exclusion Criteria:

  1. have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease, unstable diabetes, or elevated liver enzymes (SGOT or SGPT) greater than 4 times the upper limit of normal);
  2. have a current neurological disorder (e.g., organic brain disease, dementia) or major psychiatric disorder not due to substance abuse (e.g., schizophrenia or bipolar illness) as assessed by the SCID and a medical history which would make study agent compliance difficult or which would compromise informed consent, or recent (past 30 days) history of suicide attempts and/or current serious suicidal intention or plan as assessed by the SCID and the BDI-II;
  3. currently on prescription medication that is known to interact with the study drug;
  4. have current dependence on cocaine, opiates, alcohol, or benzodiazepines, as defined by DSM-IV-TR criteria;
  5. have a history of alcohol dependence within the past three years;
  6. have a history of mitral valve prolapse, left ventricular hypertrophy, cardiac arrhythmias, angina, myocardial infarction, acute coronary syndrome (unstable angina), cardiac syncope or presyncope, or any EKG abnormalities that suggests the presence of one of these conditions;
  7. have a systolic blood pressure greater than 160, a diastolic blood pressure greater than 100 (i.e. cutoffs for stage 2 hypertension), and a heart rate greater than 70% of the maximum heart rate expected for their age (0.70(220-age)) at any of the study visits.
  8. any other circumstances that, in the opinion of the investigators, would compromise participant safety;
  9. have a history of sensitivity to modafinil.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469508

Locations
United States, California
UCLA Vine Street Clinic
Hollywood, California, United States, 90038
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Steve Shoptaw, Ph.D. University of California, Los Angeles
  More Information

Additional Information:
Publications:
Responsible Party: Steve Shoptaw, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00469508     History of Changes
Obsolete Identifiers: NCT00462293
Other Study ID Numbers: P50 DA018185-03, P50DA018185
Study First Received: May 3, 2007
Results First Received: December 7, 2012
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Methamphetamine
Modafinil
Medication
Contingency Management
Crystal meth
Los Angeles
Addiction
Meth

Additional relevant MeSH terms:
Armodafinil
Methamphetamine
Modafinil
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on November 25, 2014