Modafinil, Sleep Architecture and Cocaine Relapse

NCT01137396 | Completed Phase 2 Results

• 2 other identifiers: 0911005989DA011744-08
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The medication modafinil has been shown to reduce cocaine use in some cocaine users. The investigators have shown that modafinil taken in the morning improves sleep in chronic cocaine users. The investigators hypothesize that the beneficial effects of modafinil in reducing cocaine use may be related to specific effects modafinil has on sleep. This study will measure sleep and cocaine use in cocaine dependent persons who are trying to stop using cocaine, and will test the connection between modafinil's effects on sleep and cocaine use.

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• %Cocaine Free Urines

  3x/week

Secondary Outcomes (1)

• Change in N3 (Slow-wave) Sleep Time

  change from week 1 to week 2 of inpatient treatment

Study Arms (2)

Modafinil

EXPERIMENTAL

Drug: Modafinil; Behavioral: Cognitive Behavioral Therapy

Placebo

PLACEBO COMPARATOR

Behavioral: Cognitive Behavioral Therapy

Interventions

Modafinil DRUG

Modafinil 400mg PO QDaily following up-titration for \~8weeks

Modafinil

Cognitive Behavioral Therapy BEHAVIORAL

Once weekly cognitive behavioral therapy for cocaine dependence

Modafinil; Placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age;
• voluntary, written, informed consent;
• seeking but not currently enrolled in treatment for cocaine use;
• self-reported, current use of cocaine by smoked or intravenous route at least one time each week in the past month, with ≥1g used within a single 24-hour period and ≥3g used in the month;
• positive urine test for cocaine (benzoylecognine) at the time of screening and study start
• dependence on cocaine in the past year as measured by a score ≥ 3 on the Severity of Dependence Scale(Kaye and Darke, 2002);
• chronic use in the past year as determined by self-reported use in at least 9 of the past 12 months;
• lifetime diagnosis of cocaine dependence with a duration of at least 2 years as determined by the Structured Clinical Interview for DSM-IV (SCID).

You may not qualify if:

• evidence of any neurological condition or a chronic medical condition including diabetes, cardiovascular disease or history of cardiac problems, HIV-seropositivity, liver disease, hypertension, asthma requiring daily medication, dementia, movement disorder, history of head trauma with loss of consciousness, sleep apnea, narcolepsy, restless leg syndrome, periodic limb movement disorder, REM sleep disorder, pharmacological treatment for insomnia of any type within the past 6 months, glaucoma, severe respiratory insufficiency, seizure disorder, or if in the past three months they have taken any medications that affect sleep, or are currently taking any regularly dosed prescription medication or any prn medication that is used on average more than 1x/week
• evidence of chronic sleep disorder including sleep apnea, narcolepsy, periodic limb movement disorder, restless leg syndrome as determined by medical history, Sleep Disorders Questionnaire(Douglass, 1994), or by polysomnography (following enrollment)
• current dependence on any drugs other than cocaine or nicotine or lifetime dependence on alcohol, benzodiazepines, or opiates, or any non-substance related Axis I disorder as determined by SCID
• current use of alcohol in excess of 3x/week AND 21 standard drinks/week in the past month or non-zero breathalyzer at screening or study start
• current use of cannabis in the past month
• positive urine toxicology test for opiates, methadone, amphetamines, barbiturates, benzodiazepines, PCP, methaquolone, and propoxyphene at the time of screening or positive test for any of those listed plus cannabis at the time of study start
• pregnancy as determined by serum β-HCG at screening or lactating per report
• females: unwillingness to use barrier contraceptives during sexual intercourse for the duration of the study
• known hypersensitivity to modafinil.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• Angarita GA, Canavan SV, Forselius E, Bessette A, Pittman B, Morgan PT. Abstinence-related changes in sleep during treatment for cocaine dependence. Drug Alcohol Depend. 2014 Jan 1;134:343-347. doi: 10.1016/j.drugalcdep.2013.11.007. Epub 2013 Nov 17.

  PMID: 24315572 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Modafinil; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Peter Morgan
• Organization: Yale University

peter.morgan@yale.edu

203-974-7560

Study Officials

• Peter Morgan, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 4, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 27, 2016
• Results First Posted: April 27, 2016

Record last verified: 2016-03

Locations

US (1)