Neural Mechanisms of Change During the Treatment of Alcohol Use Disorders With Prazosin

• Sponsor: University of New Mexico (Other)
• Overall Status: Completed
• CT.gov ID: NCT01916941
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 48
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The study uses neurobiological measures through brain imaging, neuropsychological measures, and selfreport measures to try to understand how an effective treatment for alcoholism works. On the whole, less than 50% of people with alcoholism get better with treatment. This study will help researchers develop better treatments for alcoholism because if the investigators know why the treatments the investigators use are working, and in whom the treatments work best, then the investigators may be able to make treatment more effective by targeting treatments to individuals who would be most likely to benefit and by guiding development of more effective treatments in the future.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Drug: Prazosin; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prazosin Prazosin titrated to 16 mg daily x 6 weeks	Drug: Prazosin
Placebo Comparator: Placebo Placebo X 6 weeks	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week) [from 2-4 weeks and from 4-6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Males and females age 18-65 meeting DSM-IV criteria for alcohol dependence in the past year;

2. seeking but not currently receiving treatment;

3. able to provide voluntary informed consent;

4. have at least 4 drinking days in the past 30 days

5. english-speaking

6. have a primary care physician or psychiatrist willing to continue prazosin if the patient tolerates it well and is finding it beneficial.

Exclusion Criteria:

1. severe neurological (e.g., head injury/stroke) conditions, Meniere's disease, narcolepsy, benign positional vertigo, heart disease or unstable angina, history of dysrhythmia/syncope, SBP<110, SBP>160, DBP>110, HR<55, HR>110, irregular heart rhythm, chronic renal or hepatic failure, pancreatitis or insulin-dependent diabetes, or other medical problems requiring immediate attention;

2. schizophrenia, schizoaffective disorder, PTSD, Bipolar I disorder, suicidal thoughts within the last month;

3. current dependence on another drug of abuse (except nicotine);

4. contraindications to MRI (e.g., pacemaker);

5. active legal problems with the potential to result in incarceration;

6. pregnancy or lactation, or child bearing age and not on birth control;

7. currently receiving treatment for alcohol dependence;

8. current use of psychoactive medications including SSRI's and other antidepressants, anti-craving medications, anxiolytics including benzodiazepines, antipsychotics, mood stabilizers or anticonvulsants;

9. history of seizures or DT's during alcohol withdrawal.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New Mexico, Department of Psychiatry	Albuquerque	New Mexico	United States	87031

Sponsors and Collaborators

• University of New Mexico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Claire E Wilcox, MD, University of New Mexico
• ClinicalTrials.gov Identifier: NCT01916941
• Other Study ID Numbers: 1K23AA021156-01A1
• First Posted: Aug 6, 2013
• Last Update Posted: Oct 17, 2017
• Last Verified: Oct 1, 2017

• Additional relevant MeSH terms: Alcoholism; Alcohol Drinking; Prazosin

Study Results

Participant Flow

Arm/Group Title	Prazosin	Placebo
Arm/Group Description	Prazosin titrated to 16 mg daily x 6 weeks Prazosin	Placebo X 6 weeks Placebo
Period Title: Overall Study
STARTED	18	18
COMPLETED	13	14
NOT COMPLETED	5	4

Baseline Characteristics

Arm/Group Title	Prazosin	Placebo	Total
Arm/Group Description	Prazosin titrated to 16 mg daily x 6 weeks Prazosin	Placebo X 6 weeks Placebo	Total of all reporting groups
Overall Participants	18	18	36
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 100%	18 100%	36 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	6 33.3%	7 38.9%	13 36.1%
Male	12 66.7%	11 61.1%	23 63.9%
Region of Enrollment (Count of Participants)
United States	18 100%	18 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week)
Time Frame	from 2-4 weeks and from 4-6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prazosin	Placebo
Arm/Group Description	Prazosin titrated to 16 mg daily x 6 weeks Prazosin	Placebo X 6 weeks Placebo
Measure Participants	18	18
from 2-4 weeks	13.65 (18.92)	14.55 (17.29)
from 4-6 weeks	15.11 (23.66)	11.11 (15.01)

Adverse Events

Arm/Group Title	Prazosin		Placebo
Arm/Group Description	Prazosin titrated to 16 mg daily x 6 weeks Prazosin		Placebo X 6 weeks Placebo
All Cause Mortality
	Prazosin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Prazosin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Prazosin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/18 (55.6%)		4/18 (22.2%)
Cardiac disorders
Dizziness on standing	10/18 (55.6%)		4/18 (22.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.