Clinical trial NCT02785406: Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use
Official title: Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Use Disorder
Anxiety
Keywords: cocaine
sleep
anxiety
craving
addiction
orexin
cue reactivity
suvorexant
Belsomra
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Peter McManus Charitable Trust
First posted: 2016-05-27
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Preclinical research has established important functions for the orexin system in mediating arousal/sleep, stress, and cue-induced reinstatement of drug taking (e.g., relapse). The role of stress/anxiety and drug cue reactivity in human drug relapse is well established, but to date, the role of the orexin system in modulating these phenomena has not been examined in humans with substance use disorders (e.g., cocaine). The goal of the present first-in-human study will be to examine the effects of an orexin antagonist (suvorexant) on interactions among stress/anxiety, sleep, and drug-cue reactivity. The study will utilize a battery of highly sensitive, drug-specific, laboratory measures of drug cue reactivity (a relapse risk model), and well-established metrics of stress/anxiety and sleep. The hypothesis is that antagonism of the orexin system will attenuate the link between (1) stress/anxiety and drug cue reactivity, and (2) sleep and drug cue reactivity. These results will elucidate a unique biochemical mechanism for understanding relapse, and provide a potential medication target for relapse prevention.

Eligibility 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.

Primary outcomes:
measure: Cue Reactivity as Assessed by the Attention Bias (AB) Task
timeFrame: day 0
measure: Cue Reactivity as Assessed by the Attention Bias (AB) Task
timeFrame: day 7
measure: Cue Reactivity as Assessed by the Attention Bias (AB) Task
timeFrame: day 14
measure: Total Sleep as Assessed by the Misfit Shine Device
timeFrame: day 0
measure: Total Sleep as Assessed by the Misfit Shine Device
timeFrame: day 2
measure: Total Sleep as Assessed by the Misfit Shine Device
timeFrame: day 4
measure: Total Sleep as Assessed by the Misfit Shine Device
timeFrame: day 7
measure: Total Sleep as Assessed by the Misfit Shine Device
timeFrame: day 9
measure: Total Sleep as Assessed by the Misfit Shine Device
timeFrame: day 11
measure: Total Sleep as Assessed by the Misfit Shine Device
timeFrame: day 14
measure: Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale
timeFrame: day 0
measure: Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale
timeFrame: day 2
measure: Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale
timeFrame: day 4
measure: Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale
timeFrame: day 7
measure: Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale
timeFrame: day 9
measure: Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale
timeFrame: day 11
measure: Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale
timeFrame: day 14
measure: Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale.
timeFrame: day 0
measure: Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale
timeFrame: day 2
measure: Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale
timeFrame: day 4
measure: Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale
timeFrame: day 7
measure: Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale
timeFrame: day 9
measure: Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale
timeFrame: day 11
measure: Anxiety as Assessed by the DASS21 Self-report Questionnaire
timeFrame: day 14
Secondary outcomes:
measure: Cue Reactivity as Assessed by the Cocaine Craving Questionnaire (CCQ) Brief
timeFrame: day 0, day 7, and day 14
measure: Sleep Quality as by the Pittsburg Sleep Quality Index (PSQI)
timeFrame: day 0, day 2, day 4, day 7, day 9, day 11, and day 14
measure: Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Systolic Blood Pressure
timeFrame: day 0, day 7, and day 14
measure: Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Diastolic Blood Pressure
timeFrame: day 0, day 7, and day 14
measure: Stress/Anxiety as Assessed by Cortisol Level During the Cold Pressor Test (CPT)
timeFrame: day 0, day 7, and day 14
measure: Stress as Assessed by a Visual Analog Scale (VAS) for Stress
timeFrame: day 0, day 2, day 4, day 7, day 9, day 11, and day 14
measure: Percent Medication Compliance as Assessed by the Medical Event Monitoring System (MEMS, Aprex Corporation) Bottles
timeFrame: day 2, day 4, day 7, day 9, day 11, and day 14
measure: Percent Medication Compliance as Assessed by Pill Counts
timeFrame: day 2, day 4, day 7, day 9, day 11, and day 14
measure: Percent Medication Compliance as Assessed by Analysis of Riboflavin Markers in Urine Samples
timeFrame: day 2, day 4, day 7, day 9, day 11, and day 14
measure: Percent Medication Compliance as Assessed by Text Reminders and Replies
timeFrame: day 2, day 4, day 7, day 9, day 11, and day 14
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Scott D. Lane, PhD
role: PRINCIPAL_INVESTIGATOR
References: