Open-Label, Safety Study of Lofexidine

Eligible subjects (person seeking treatment for partial or total opioid withdrawal) enrolled
in this study are required to take lofexidine for a minimum of 7 days.

Inclusion Criteria:

- Male or Female at least 18 years of age

- Must be able to verbalize understanding of the consent form, able to provide written
informed consent, and verbalize willingness to complete study procedures

- Must have current dependence, according to the Mini International Neuropsychiatric
Interview (M.I.N.I.), on any opioid (including methadone and buprenorphine maintenance
treatment)

- Must be seeking treatment for partial or total withdrawal from current opioid and
expected, as determined by the Principal Investigator, to benefit from lofexidine
treatment for at least 7 days at clinically relevant doses. This can include a variety
of clinical situations where opioid withdrawal illness is likely to occur including
abrupt and total withdrawal (including from methadone and buprenorphine),
agonist-assisted total withdrawal, dose reduction of maintenance treatment (e.g.,
methadone, buprenorphine) and transition from an opioid agonist to naltrexone or
buprenorphine maintenance

- Must have Urine toxicology screen result of positive for opioid(s) relevant to the
subject's withdrawal treatment goal

- If female and of childbearing potential, subject must agree to use of one of the
following methods of birth control including oral contraceptives, patch, barrier
(diaphragm, sponge or condom) plus spermicidal preparations, intrauterine
contraceptive system, levonorgestrel implant, medroxyprogesterone acetate
contraceptive injection, complete abstinence from sexual intercourse, hormonal vaginal
contraceptive ring or surgical sterilization or partner sterile (with documented
proof)

Exclusion Criteria:

- Female subject who is pregnant or lactating

- History of very serious medical illness not under control including, but not limited
to, active self-reported acquired immune deficiency syndrome (AIDS) or self-reported
human immunodeficiency virus (HIV) positive status and taking retroviral medications
currently or within the past 4 weeks and/or having an unstable psychiatric condition.
These conditions will be determined at Screening by medical history, physical
examination, 12 lead electrocardiogram (duplicate), clinical laboratory tests for
infectious diseases, and a tuberculin test

- Current dependence (based on the M.I.N.I.) on any psychoactive substance (excluding
caffeine, nicotine, and the subject's current opioid-dependence agent, which can
include methadone and buprenorphine, for example, in agonist-maintained subjects) that
requires detoxification or dose reduction as part of the pre-defined individual
subject withdrawal treatment goal

- Have participated in an investigational drug study within the past 30 days

- Have a history of lofexidine exposure in a prior clinical trial or otherwise

- Have an abnormal cardiovascular exam at screening

- Any subject that requires tricyclic antidepressants, which may reduce the efficacy of
imidazoline derivatives and/or beta-receptor blockers, to avoid the risk of excessive
bradycardia