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

• Status: Completed
• Trial end date: 2018-11-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Peter F. McManus Charitable Trust
• Treatments: Cocaine; Suvorexant

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.