NCT00240227

Brief Summary

This double-blind placebo controlled crossover pilot trial will test the hypothesis that prazosin, an alpha-1 adrenergic receptor antagonist, reduces craving for their drug of choice in cocaine-dependent and alcohol-dependent veterans. Both the study medication period and the placebo period are each 4 weeks in duration.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

March 14, 2016

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

4.8 years

First QC Date

October 13, 2005

Results QC Date

November 25, 2013

Last Update Submit

August 1, 2018

Conditions

AlcoholismCocaine Dependence

Keywords

AlcoholismCocaine DependencePrazosinSubstance use disorders

Outcome Measures

Primary Outcomes (1)

  • Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group

    During lab session

Secondary Outcomes (5)

  • Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group

    During lab session

  • Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group

    During lab session

  • Change in Subjective Experience of Craving in Response to Provocative Visual Cues Designed to Elicit Craving, as Measured by the Within Session Rating for Cocaine/Alcohol Craving

    During lab session

  • Change in Self-reports of Substance Use Between Study Medication and Placebo Periods

    4 weeks

  • Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods

    4 weeks

Study Arms (2)

Placebo

OTHER

Placebo no active medication

Drug: placebo

prazosin

ACTIVE COMPARATOR

Prazosin flexible dose titration up to 12 mg per day.

Drug: Prazosin

Interventions

PrazosinDRUG

FDA approved medication for hypertension

Also known as: Mini Press
prazosin
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • Current DSM-IV diagnosis of alcohol dependence or cocaine dependence with no use in last 30 days
  • Capacity to provide informed consent
  • Actively enrolled in chemical dependency treatment at VA Puget Sound English fluency

You may not qualify if:

  • Evidence of significant abuse of opiates, PCP, sedatives or anxiolytics
  • Suicidal ideation
  • DSM IV diagnosis of bipolar mood disorder, schizophrenia or schizoaffective disorder
  • Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic \< 110), or orthostatic hypotension (systolic drop \> 20mmHg after two minutes standing or any drop with dizziness), insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, M ni re's disease, benign positional vertigo, narcolepsy
  • Concomitant use of alpha-1 antagonists History of prazosin-sensitivity Women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the investigator to be effective
  • Non-compliance with outpatient chemical dependency treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

AlcoholismCocaine-Related DisordersSubstance-Related Disorders

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

The study procedure intended to induce substance craving failed to induce craving. Thus, any difference between placebo and active medication conditions could not be measured and so the study was terminated.

Results Point of Contact

Title
Andrew J. Saxon, M.D.
Organization
VA Puget Sound Health Care System
andrew.saxon@va.gov
206-764-2782

Study Officials

  • Andrew J. Saxon, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

April 1, 2004

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 31, 2018

Results First Posted

March 14, 2016

Record last verified: 2018-08

Locations

US(1)