Vigabatrin for the Treatment of Cocaine Dependency



Status:Completed
Conditions:Psychiatric, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2011
End Date:December 2012

Use our guide to learn which trials are right for you!

Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent
subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use
of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher
than seen in subjects treated with placebo in addition to counseling.

The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent
subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use
of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher
than seen in subjects treated with placebo in addition to counseling.

There are 3 Phases to this study:

- a 2-4 week Screening/Baseline Phase during which eligibility to be included in the
trial will be tested;

- a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets
in addition to counseling; and

- a 15 week Follow-up Phase, during the first 4 weeks (Weeks 10-13) of which subjects
will continue to receive counseling.

Inclusion Criteria:

- Able to understand the study and provide written informed consent.

- Male or female at least 18 years of age.

- Meet DSM-IV criteria for cocaine dependence as primary diagnosis, as determined by
the Substance Abuse Structured Clinical Interview (SCID) for Diagnostic and
Statistical Manual-IV (DSM-IV) module.

- Have a verifiable place of primary residence.

- Seeking treatment for cocaine dependence.

- Be in generally good health based on history, physical examination,
electrocardiogram, eye exam and laboratory findings.

- If female of childbearing potential, use acceptable contraceptive methods (oral
contraceptives (the pill), intrauterine device (IUD), contraceptive implants under
the skin, contraceptive rings or patches or injections, diaphragms with spermicide,
and condoms with spermicide). Surgical sterilization by tubal ligation or
hysterectomy is acceptable.

Exclusion Criteria:

- Please contact site for more information
We found this trial at
13
sites
72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Boston University School of Medicine A leader in medical education and research, Boston University School...
?
mi
from
Boston, MA
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Dallas, Texas 75243
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80220
?
mi
from
Denver, CO
Click here to add this to my saved trials
Los Angeles, California 90016
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Oak Brook, IL
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Salt Lake City, Utah 84148
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials