Clinical Trial: Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Biobehavioral Studies of Opioid Seeking: Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence

Brief Summary: This research deals with behaviors that are part of opioid dependence. The purpose is to study how stress and medication dose can affect opioid drug use.

Detailed Summary:

This study will last for about 6-months. Participants will live on a residential unit for a minimum of 3 nights on 4 separate weeks (every other week). Participants will live on the residential unit for a total of 12 nights over this 7-week period. During that time, participants can't leave the unit unescorted or have visitors.

For the entire 11-week time, participants will receive a medication called Buprenorphine/Naloxone. Buprenorphine/Naloxone is approved by the Food and Drug Administration (FDA) to treat opioid addiction, and is a safe and effective alternative to methadone. Participants will receive this medication every day. When participants are not living on the inpatient unit they will come to the research clinic every day to receive the medication.

On the 12 days while participants are an inpatient they will participate in experimental sessions that involve drug administration. On some days participants will receive morphine and on some days participants will receive oral medications called yohimbine and hydrocortisone that will be used to study stress responses.

At the end of the study participants will be detoxified from the Buprenorphine/Naloxone medication over a 4-week outpatient period.

Finally, after the detoxification phase is complete participants will be asked to come in for 3 separate in-person follow-up visits in which participants will be asked to provide a urine sample and will be asked questions about their drug use.


Sponsor: Wayne State University

Current Primary Outcome: Opioid Use Urine Drug Testing [ Time Frame: Change is being assessed. Urine Drug Testing will occur during inpatient stay and be re-evaluated at 1, 2 and 3 month follow-up visits after completing the dose taper. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Opioid Symptom Questionnaire (Self-Report Measure) [ Time Frame: Change is being assessed. Self-report measure will be obtained at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600. ]
    Opioid Agonist (16 items) and Withdrawal (16 items) symptoms will be assessed using a 32-item inventory.
  • Visual Analog Scales (VAS) (Self-Report Measure) [ Time Frame: Change is being assessed. Self-report measure will be obtained at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600. ]
    VAS ratings will measure "liking", "good drug effect," "bad drug effect," "stimulated," "sedated", "[preferred opioid] craving", and "cigarette craving". Each VAS is scored from 0 (not at all) to 100 (extremely).
  • Profile of Mood States (Self-Report Measure) [ Time Frame: Change is being assessed. Self-report measure will be obtained at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600. ]
    Mood state will be measured using a modified Profile of Mood States with 72 adjectives.
  • Systolic blood pressure (physiological effects) [ Time Frame: Change is being assessed. Measurements will be obtained at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600. ]
  • Diastolic blood pressure (physiological effects) [ Time Frame: Change is being assessed. Measurements will be obtained at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600. ]
  • Heart rate (physiological effects) [ Time Frame: Change is being assessed. Measurements will be obtained at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600. ]
  • Respiration Rate (physiological effects) [ Time Frame: Change is being assessed. Measurements will be obtained at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600. ]
  • Oxygen saturation (physiological effects) [ Time Frame: Change is being assessed. Measurements will be obtained at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600. ]
  • Pupil diameter (physiological effects) [ Time Frame: Change is being assessed. Measurements will be obtained at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600. ]


Original Secondary Outcome: Same as current

Information By: Wayne State University

Dates:
Date Received: December 16, 2016
Date Started: December 2016
Date Completion: December 2020
Last Updated: April 20, 2017
Last Verified: April 2017