Varenicline for Methamphetamine Dependence
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/20/2018 |
| Start Date: | February 2012 |
| End Date: | August 2014 |
Varenicline for Methamphetamine Dependence: Phase II Clinical Trial
Methamphetamine (MA) dependence is a source of continuing danger for both individuals and
society. While there are some behavioral treatments, they are not always effective. To date,
there are no medications available to treatment methamphetamine dependence. There is some
early evidence suggesting that varenicline (also known as Chantix(tm)) may help people to
stop or reduce their use of methamphetamine. Varenicline is already on the market in the U.S.
for cigarette smoking cessation and shows promise for treating alcohol dependence. In order
to determine if varenicline can help people stop using methamphetamine, we will enroll 90
methamphetamine-dependent people who are looking for treatment into the study at the UCLA
Vine Street Clinic operated by Dr Shoptaw of UCLA. Half will receive varenicline (n=45) and
half will receive placebo (n=45) which will be determined randomly. Everyone will receive
talk therapy for methamphetamine dependence. People will take the medication for 9 weeks
followed by a 4 week follow-up period. Before receiving any medication, participants will
complete a maximum 2 week (6 study visits) lead-in to complete baseline assessments,
psychological and medical evaluation, and comprehensive assessment of drug use to determine
study eligibility. If a person is eligible for the study, s/he will receive either
varenicline or placebo. Participants will visit the UCLA Vine Street Clinic (UCLA VSC) three
times a week study visits. At the end of the medication phase, subjects will complete a four
week follow up period for safety monitoring.
society. While there are some behavioral treatments, they are not always effective. To date,
there are no medications available to treatment methamphetamine dependence. There is some
early evidence suggesting that varenicline (also known as Chantix(tm)) may help people to
stop or reduce their use of methamphetamine. Varenicline is already on the market in the U.S.
for cigarette smoking cessation and shows promise for treating alcohol dependence. In order
to determine if varenicline can help people stop using methamphetamine, we will enroll 90
methamphetamine-dependent people who are looking for treatment into the study at the UCLA
Vine Street Clinic operated by Dr Shoptaw of UCLA. Half will receive varenicline (n=45) and
half will receive placebo (n=45) which will be determined randomly. Everyone will receive
talk therapy for methamphetamine dependence. People will take the medication for 9 weeks
followed by a 4 week follow-up period. Before receiving any medication, participants will
complete a maximum 2 week (6 study visits) lead-in to complete baseline assessments,
psychological and medical evaluation, and comprehensive assessment of drug use to determine
study eligibility. If a person is eligible for the study, s/he will receive either
varenicline or placebo. Participants will visit the UCLA Vine Street Clinic (UCLA VSC) three
times a week study visits. At the end of the medication phase, subjects will complete a four
week follow up period for safety monitoring.
Methamphetamine (MA) dependence is a significant source of deleterious consequences to
individual and public health including HIV infection, psychological distress, and
cardiovascular disease. Behavioral treatments, including cognitive behavioral therapy and
contingency management are available, but are modestly effective. Although pharmacotherapy
may improve treatment outcomes, ten years of randomized, placebo-controlled trials of
medications for MA dependence have failed to identify a medication with a robust effect in
generalized populations of MA users.
Cholinergic mechanisms are important in the neurobiology of MA dependence. Varenicline is a
α4β2 nicotinic receptor partial agonist and α7 nicotinic receptor full agonist that is
approved for cigarette smoking cessation and shows promise for treating alcohol dependence.
Varenicline may be effective for the treatment of MA dependence due to: (1) restoration of
MA-related dopaminergic deficits via binding to α4β2 receptors in striatal dopaminergic (DA)
neurons, (2) reductions in cigarette smoking and the associated nicotine-mediated
potentiation of MA effects, (3) activation of the nicotinic cholinergic systems that mediate
reductions in reinstatement of MA seeking seen with cannabinoid receptor antagonists and
acetylcholinesterase inhibitors, (4) relief of MA-related glutamatergic deficits via α7
nicotinic acetylcholine (ACh) receptor activation, and (5) reduction in MA-related cognitive
dysfunction via the cognitive enhancing effects of cholinergic agonists.
The investigators will enroll 90 treatment seeking, MA-dependent participants who will be
randomly assigned to receive varenicline (n=45) or placebo (n=45), in conjunction with
cognitive behavioral therapy (CBT) for 9 weeks followed by a 4 week follow-up period. Prior
to enrollment in the trial, participants will complete a maximum 2 week (6 study visits)
lead-in to complete baseline assessments, psychological and medical evaluation, and
comprehensive assessment of drug use to determine study eligibility. Once determined to be
eligible for the trial, participants will be randomly assigned to varenicline or placebo and
will start study medication. Similar to smoking cessation treatment, participants will
undergo dose escalation to varenicline 1 mg BID (or placebo BID) over one week as
outpatients. Participants will have regular clinic visits at the UCLA Vine Street Clinic
(UCLA VSC) for thrice-weekly study visits. At the end of the medication phase, subjects will
complete a four-week follow up period for safety monitoring.
individual and public health including HIV infection, psychological distress, and
cardiovascular disease. Behavioral treatments, including cognitive behavioral therapy and
contingency management are available, but are modestly effective. Although pharmacotherapy
may improve treatment outcomes, ten years of randomized, placebo-controlled trials of
medications for MA dependence have failed to identify a medication with a robust effect in
generalized populations of MA users.
Cholinergic mechanisms are important in the neurobiology of MA dependence. Varenicline is a
α4β2 nicotinic receptor partial agonist and α7 nicotinic receptor full agonist that is
approved for cigarette smoking cessation and shows promise for treating alcohol dependence.
Varenicline may be effective for the treatment of MA dependence due to: (1) restoration of
MA-related dopaminergic deficits via binding to α4β2 receptors in striatal dopaminergic (DA)
neurons, (2) reductions in cigarette smoking and the associated nicotine-mediated
potentiation of MA effects, (3) activation of the nicotinic cholinergic systems that mediate
reductions in reinstatement of MA seeking seen with cannabinoid receptor antagonists and
acetylcholinesterase inhibitors, (4) relief of MA-related glutamatergic deficits via α7
nicotinic acetylcholine (ACh) receptor activation, and (5) reduction in MA-related cognitive
dysfunction via the cognitive enhancing effects of cholinergic agonists.
The investigators will enroll 90 treatment seeking, MA-dependent participants who will be
randomly assigned to receive varenicline (n=45) or placebo (n=45), in conjunction with
cognitive behavioral therapy (CBT) for 9 weeks followed by a 4 week follow-up period. Prior
to enrollment in the trial, participants will complete a maximum 2 week (6 study visits)
lead-in to complete baseline assessments, psychological and medical evaluation, and
comprehensive assessment of drug use to determine study eligibility. Once determined to be
eligible for the trial, participants will be randomly assigned to varenicline or placebo and
will start study medication. Similar to smoking cessation treatment, participants will
undergo dose escalation to varenicline 1 mg BID (or placebo BID) over one week as
outpatients. Participants will have regular clinic visits at the UCLA Vine Street Clinic
(UCLA VSC) for thrice-weekly study visits. At the end of the medication phase, subjects will
complete a four-week follow up period for safety monitoring.
Inclusion Criteria:
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Exclusion Criteria:
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