Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use

Completed · Phase 2 · Has a placebo group

Conditions studied: Cocaine Use Disorder, Anxiety

In brief

The purpose of this study is to determine the effectiveness of a medication called suvorexant in reducing anxiety, improving sleep, and reducing cocaine cravings or cocaine use.

Key facts

Study ID

NCT02785406

Run by

The University of Texas Health Science Center, Houston

People needed

20

Starts

2016-05-01

Expected to finish

2018-11-15

Last updated by the study team

2019-12-11

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• meet current DSM-5 criteria for cocaine use disorder (CUD) of at least moderate severity (≥4 symptoms)

You may not qualify if…

• current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine
• have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
• significant current suicidal or homicidal ideation
• medical conditions contraindicating administration of suvorexant (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal EEG, severe liver or kidney disease, seizure disorder, or sleep disorder - particularly narcolepsy)
• taking medications known to have significant drug interactions with the study medication(s) (e.g., MAO inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and all sedatives)
• currently or recently (last 3 months) treated for substance use [other than cocaine or nicotine] or another psychiatric condition
• conditions of probation or parole requiring reports of drug use to officers of the court; (8) impending incarceration
• pregnant or nursing for female patients
• inability to read, write, or speak English [required for lab tasks and psychometric scales]
• unwillingness to sign a written informed consent form
• subjects with alcohol use disorders or are drinking > 7 alcoholic drinks per week. All subjects who are excluded will be given referral information to other local treatment programs.

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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