NCT00684840

Brief Summary

The purpose is to study the extent to which stress and other factors, including money, the amount of drug available and the amount of work effort, affect drug choice. This study will assess whether exposure to yohimbine, a drug stressor, increases opioid craving- and -seeking behavior. We will determine whether these behavioral outcomes are associated with biobehavioral stress markers: increased saliva cortisol levels, cardiovascular response (heart rate and blood pressure), and negative mood state.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

3.8 years

First QC Date

May 23, 2008

Last Update Submit

June 1, 2012

Conditions

Heroin DependenceOpioid-Related Disorders

Keywords

Behavioral EconomicsDrug self administrationOpioid

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Heroin dependent research volunteers

You may qualify if:

  • 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

You may not qualify if:

  • Psychiatric illness, as determined by the DSM-IV criteria
  • History of or current neurological disease, including structural abnormalities, seizures, infection, peripheral neuropathy, and head traumas
  • History of cardiovascular disease, myocardial infarction, chest pain, or edema
  • Systolic blood pressure greater than 160mm HG or less than 95 mm HG: PR diastolic blood pressure greater than 95 mm HG.
  • Pulmonary disease, including obstructive pulmonary disease, Cor pulmonale, tuberculosis, and asthma
  • Systemic disease (e.g. endocrinopathies, liver or kidney failure, myxedema, hypothyroidism, Addison's disease, autoimmune disease)
  • Current alcohol or sedative drug dependence
  • Pregnant or breast feeding
  • Currently receiving treatment for opioid dependence
  • Known phobia of injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (3)

  • Woodcock EA, Lundahl LH, Burmeister M, Greenwald MK. Functional mu opioid receptor polymorphism (OPRM1 A(118) G) associated with heroin use outcomes in Caucasian males: A pilot study. Am J Addict. 2015 Jun;24(4):329-35. doi: 10.1111/ajad.12187. Epub 2015 Apr 24.

    PMID: 25911999DERIVED

  • Stoltman JJ, Woodcock EA, Lister JJ, Greenwald MK, Lundahl LH. Exploration of the telescoping effect among not-in-treatment, intensive heroin-using research volunteers. Drug Alcohol Depend. 2015 Mar 1;148:217-20. doi: 10.1016/j.drugalcdep.2015.01.010. Epub 2015 Jan 19.

    PMID: 25630964DERIVED

  • Greenwald MK, Lundahl LH, Steinmiller CL. Yohimbine increases opioid-seeking behavior in heroin-dependent, buprenorphine-maintained individuals. Psychopharmacology (Berl). 2013 Feb;225(4):811-24. doi: 10.1007/s00213-012-2868-9. Epub 2012 Nov 17.

    PMID: 23161001DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Heroin DependenceOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Mark Greenwald, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

US(1)