NCT00429767

Brief Summary

The purpose of this study is to determine whether maintenance on different oral doses of sustained release d-amphetamine (SR-AMP) combined with constant-dose sublingual buprenorphine (BUP) is safe and well tolerated and decreases self-administration of cocaine alone or combined with hydromorphone (HYD). Secondary aims are to determine whether SR-AMP attenuates the subjective and physiological effects of cocaine during drug sampling periods prior to choice opportunities.

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 Jan 2007

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

January 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

3 years

First QC Date

January 30, 2007

Last Update Submit

June 1, 2012

Conditions

Heroin DependenceOpioid-Related DisordersCocaine Abuse or Dependence

Keywords

OpioidCocaineDrug Self Administration

Eligibility Criteria

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

Heroin dependent and Cocaine abuse or dependent research volunteers.

You may qualify if:

  • Opioid dependent and Cocaine abuse or dependence, as determined by structured clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)
  • Positive urine test for opiates and cocaine
  • 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, infectious disease, history of other neurological diseases or head trauma.
  • History of cardiovascular disease, myocardial infarction, chest pain or palpations on exertion or drug use
  • Systolic blood pressure greater than 160 or less than 95 mmHg; Diastolic blood pressure \>95 mmHg
  • Clinically abnormal ECG
  • Pulmonary disease, including asthma, obstructive pulmonary disease, cor pulmonale, tuberculosis
  • Systemic disease (e.g., endocrinopathies, liver or kidney failure, myxedema, hypothyroidism, Addison's disease, autoimmune disease)
  • Current alcohol or sedative drug dependence
  • Pregnant or breastfeeding
  • Currently receiving treatment for a Substance Abuse/Dependence Disorder or seeking treatment
  • Been in a research study within the last 30 days
  • Known phobia of injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48207, United States

Location

Related Publications (2)

  • 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. Sustained release d-amphetamine reduces cocaine but not 'speedball'-seeking in buprenorphine-maintained volunteers: a test of dual-agonist pharmacotherapy for cocaine/heroin polydrug abusers. Neuropsychopharmacology. 2010 Dec;35(13):2624-37. doi: 10.1038/npp.2010.175. Epub 2010 Sep 29.

    PMID: 20881947DERIVED

MeSH Terms

Conditions

Heroin DependenceOpioid-Related DisordersCocaine-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

January 30, 2007

First Posted

February 1, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

US(1)