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Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence (BOS)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Mark Greenwald, PhD, Wayne State University
Sponsor:
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University
ClinicalTrials.gov Identifier:
NCT03015246
First received: December 16, 2016
Last updated: April 20, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Heroin Dependence Opioid Use Disorder Drug: Buprenorphine-Naloxone Drug: Morphine Drug: Yohimbine Drug: Hydrocortisone Drug: Matching Placebo for Yohimbine Drug: Matching Placebo for Hydrocortisone Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Biobehavioral Studies of Opioid Seeking: Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence

Resource links provided by NLM:


Further study details as provided by Mark Greenwald, PhD, Wayne State University:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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. ]

Estimated Enrollment: 40
Study Start Date: December 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buprenorphine-Naloxone

Participants will be maintained on Buprenorphine-Naloxone (Zubsolv™) sublingual tablets.

Every participant will be maintained two weeks at each dosage level, in randomized order, on Buprenorphine-Naloxone (Zubsolv™) doses of 1.4/0.36 mg/day, 4.2/1.08 mg/day, and 12.8/3.16 mg/day.

Drug: Buprenorphine-Naloxone
To blind the varying maintenance doses, on each protocol day the participant will always take a total of 4 tablets at the same time, with a mixture of active and placebo tablets. Total daily doses will differ, depending on the periods/weeks within each study phase.
Other Name: Zubsolv™
Drug: Morphine
During each participant's first experimental week, one morphine dose will be administered orally at 9:00 pm the evening prior to each of the 3 inpatient experimental sessions.
Drug: Yohimbine
Yohimbine (or matching placebo)will be administered at 12:00pm on each of the experimental sessions.
Drug: Hydrocortisone
Hydrocortisone or matching placebo will be administered 45 min after Yohimbine.
Drug: Matching Placebo for Yohimbine
Yohimbine (or matching placebo) will be administered at 12:00pm on each of the experimental sessions.
Drug: Matching Placebo for Hydrocortisone
Hydrocortisone or matching placebo will be administered 45 min after Yohimbine.
Buprenorphine-Naloxone Stabilization
After completing the three Buprenorphine-Naloxone maintenance-dose conditions, each participant will be stabilized on a daily dose of Buprenorphine-Naloxone 4.2/1.08 mg for one week, then the daily dose will be tapered over 3 weeks to 2.8/0.72 mg (week 1), 1.4/0.36 mg (week 2) and 0/0 mg (week 3).
Drug: Buprenorphine-Naloxone
To blind the varying maintenance doses, on each protocol day the participant will always take a total of 4 tablets at the same time, with a mixture of active and placebo tablets. Total daily doses will differ, depending on the periods/weeks within each study phase.
Other Name: Zubsolv™

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Opioid dependent, as determined by structured clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)
  • Positive urine test for opiates
  • Willing to use an adequate form of contraception for the duration of the study.
  • Reads and writes English
  • Participants must be in generally good health to be eligible. All candidates will receive a routine medical exam (history and physical) with standard laboratory tests (including blood and urine samples, EKG, mandatory TB testing, and voluntary HIV testing).

Exclusion Criteria:

  • No candidate who has a current DSM-IV Axis I disorder other than Drug Dependence or a history of serious psychiatric problems (e.g. psychosis, bipolar or major depression) will be allowed to participate.
  • Candidates meeting criteria for opioid or nicotine dependence will not be excluded, but those with other Substance Dependence disorders will be excluded. Those with Abuse of Alcohol, Cannabis, Cocaine, will not be excluded, but participants must provide an alcohol free breath specimen.
  • No candidate with medical (neurological, cardiovascular, pulmonary or systemic) disorders will be allowed to participate. This will be determined with history and physical exam, standard laboratory testing (blood and urine), EKG, and TB tests (to avoid transmitting this communicable disease on the residential unit or in the laboratory).
  • Candidates with evidence of cognitive impairment (based on reading ability and comprehension, will be excluded.
  • Female candidates who are pregnant (urine pregnancy test), lactating, or not using adequate birth control methods (self-report) will be excluded.
  • Candidates with injection phobia, or seeking treatment for opioid dependence will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03015246

Contacts
Contact: Lisa Sulkowski, B.S. 313-993-3966 lsulkows@med.wayne.edu

Locations
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Lisa Sulkowski, B.S    313-993-3966    lsulkows@med.wayne.edu   
Principal Investigator: Mark Greenwald, PhD         
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Mark Greenwald, PhD Wayne State University
  More Information

Responsible Party: Mark Greenwald, PhD, Professor (Tenured) of Psychiatry and Behavioral Neurosciences; and Director, Substance Abuse Research Division, Wayne State University
ClinicalTrials.gov Identifier: NCT03015246     History of Changes
Other Study ID Numbers: BOS-1
Study First Received: December 16, 2016
Last Updated: April 20, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Morphine
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Yohimbine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Anti-Inflammatory Agents
Mydriatics
Autonomic Agents
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 26, 2017