Modafinil vs Placebo for the Treatment of Methamphetamine Dependence

NCT00469508 | Completed Phase 2 Results DMC

• 2 other identifiers: P50DA018185-03P50DA018185
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methamphetamine Dependence

Keywords

Methamphetamine; Modafinil; Medication; Contingency Management; Crystal meth; Los Angeles; Addiction; Meth

Outcome Measures

Primary Outcomes (1)

• Clean Urine Drug Screen

  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.

  From randomization to end of week 12

Secondary Outcomes (1)

• Retention

  12 weeks

Other Outcomes (2)

• VAS Score

  baseline and last observation during the 12 week treatment period

• BDI Score

  From baseline to end of treatment period (week 12).

Study Arms (2)

Modafinil

ACTIVE COMPARATOR

Modafinil 400mg oral dose taken daily for 12 weeks

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks

Drug: Placebo

Interventions

Modafinil DRUG

400mg pills taken orally daily for 12 wks.

Also known as: Provigil

Modafinil

Placebo DRUG

400mg pills taken orally daily for 12 wks

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• meet DSM-IV criteria for methamphetamine dependence;
• willing and able to comply with study procedures;
• willing and able to provide written informed consent;
• 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).

You may not qualify if:

• 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);
• 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;
• currently on prescription medication that is known to interact with the study drug;
• have current dependence on cocaine, opiates, alcohol, or benzodiazepines, as defined by DSM-IV-TR criteria;
• have a history of alcohol dependence within the past three years;
• 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;
• 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.
• any other circumstances that, in the opinion of the investigators, would compromise participant safety;
• have a history of sensitivity to modafinil.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UCLA Vine Street Clinic

Hollywood, California, 90038, United States

Location

Related Publications (3)

• Heinzerling KG, Swanson AN, Kim S, Cederblom L, Moe A, Ling W, Shoptaw S. Randomized, double-blind, placebo-controlled trial of modafinil for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2010 Jun 1;109(1-3):20-9. doi: 10.1016/j.drugalcdep.2009.11.023. Epub 2010 Jan 25.

  PMID: 20092966 RESULT

• Heinzerling KG, Shoptaw S. Gender, brain-derived neurotrophic factor Val66Met, and frequency of methamphetamine use. Gend Med. 2012 Apr;9(2):112-20. doi: 10.1016/j.genm.2012.02.005. Epub 2012 Mar 23.

  PMID: 22445683 RESULT

• Heinzerling KG, McCracken JT, Swanson AN, Ray LA, Shoptaw SJ. COMT Val158Met, BDNF Val66Met, and OPRM1 Asn40Asp and methamphetamine dependence treatment response: preliminary investigation. J Clin Psychopharmacol. 2012 Feb;32(1):135-7. doi: 10.1097/JCP.0b013e318240a48e. No abstract available.

  PMID: 22217949 RESULT

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Modafinil; Sugars

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Limitations and Caveats

study is powered to detect at least a moderate effect for modafinil (d = 0.50) in the overall sample; subgroups may be more meaningful

Results Point of Contact

• Title: Steven Shoptaw PhD
• Organization: UCLA Center for Behavioral and Addiction Medicine

sshoptaw@mednet.ucla.edu

310 794 0619

Study Officials

• Steve Shoptaw, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 2, 2020
• Results First Posted: March 15, 2013

Record last verified: 2020-02

Locations

US (1)