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

NCT02785406 | Completed Phase 2 Results DMC

• 1 other identifier: HSC-MS-16-0120
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Use Disorder; Anxiety

Keywords

cocaine; sleep; anxiety; craving; addiction; orexin; cue reactivity; suvorexant; Belsomra

Outcome Measures

Primary Outcomes (24)

• Cue Reactivity as Assessed by the Attention Bias (AB) Task

  The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome.

  day 0

• Cue Reactivity as Assessed by the Attention Bias (AB) Task

  The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome.

  day 7

• Cue Reactivity as Assessed by the Attention Bias (AB) Task

  The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome.

  day 14

• Total Sleep as Assessed by the Misfit Shine Device

  Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.

  day 0

• Total Sleep as Assessed by the Misfit Shine Device

  Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.

  day 2

• Total Sleep as Assessed by the Misfit Shine Device

  Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.

  day 4

• Total Sleep as Assessed by the Misfit Shine Device

  Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.

  day 7

• Total Sleep as Assessed by the Misfit Shine Device

  Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.

  day 9

• Total Sleep as Assessed by the Misfit Shine Device

  Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.

  day 11

• Total Sleep as Assessed by the Misfit Shine Device

  Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.

  day 14

• Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.

  day 0

• Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.

  day 2

• Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.

  day 4

• Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.

  day 7

• Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.

  day 9

• Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.

  day 11

• Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.

  day 14

• Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale.

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.

  day 0

• Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.

  day 2

• Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.

  day 4

• Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.

  day 7

• Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.

  day 9

• Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.

  day 11

• Anxiety as Assessed by the DASS21 Self-report Questionnaire

  DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.

  day 14

Secondary Outcomes (10)

• Cue Reactivity as Assessed by the Cocaine Craving Questionnaire (CCQ) Brief

  day 0, day 7, and day 14

• Sleep Quality as by the Pittsburg Sleep Quality Index (PSQI)

  day 0, day 2, day 4, day 7, day 9, day 11, and day 14

• Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Systolic Blood Pressure

  day 0, day 7, and day 14

• Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Diastolic Blood Pressure

  day 0, day 7, and day 14

• Stress/Anxiety as Assessed by Cortisol Level During the Cold Pressor Test (CPT)

  day 0, day 7, and day 14

Study Arms (2)

suvorexant

EXPERIMENTAL

Subjects will receive suvorexant (10 mg week 1, 20 mg week 2), once daily at 10 PM.

Drug: suvorexant

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo once daily at 10 PM.

Drug: Placebo (for suvorexant)

Interventions

suvorexant DRUG

Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM.

Also known as: Belsomra

suvorexant

Placebo (for suvorexant) DRUG

Subjects will receive placebo capsules once daily at 10 PM.

Also known as: corn starch

Placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Peter McManus Charitable Trust: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Behavior, Addictive

Interventions

suvorexant; Starch

Condition Hierarchy (Ancestors)

Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Results Point of Contact

• Title: Scott Lane
• Organization: The University of Texas Health Science Center at Houston

Scott.D.Lane@uth.tmc.edu

713-486-2535

Study Officials

• Scott D. Lane, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 27, 2016
• Study Start: May 1, 2016
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: December 11, 2019
• Results First Posted: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)