Varenicline vs Placebo for the Treatment of Methamphetamine Dependence

NCT01011829 | Completed Phase 2 Results DMC

• 3 other identifiers: NIDA-18185-PII-3P50DA018185DPMC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Methamphetamine (MA) abuse is the fastest growing drug problem in the United States and is responsible for significant public health complications, including HIV infection. As a result effective treatments for MA dependence are urgently needed. There are currently no efficacious medications for MA dependence, although results from preliminary randomized trials of bupropion for MA dependence found bupropion to be more effective than placebo, but only among subgroups of participants, including those with lower frequency of MA use at baseline. A growing body of preclinical and clinical studies suggest that cholinergic mechanisms play an important role in the neurobiology of MA and other stimulant dependence, such as nicotine dependence. Mechanistically, cholinergic medications may alleviate MA-associated cognitive dysfunction, thereby improving outcomes of treatment for MA dependence. Varenicline is a partial agonist at α4β2 nicotinic receptors and a full agonist at α7 nicotinic receptors that has been approved as an anti-cigarette smoking medication. In order to assess the potential efficacy of varenicline for methamphetamine dependence, we will perform a clinical trial to assess if varenicline compared to placebo results in greater:

1. 1.reductions in methamphetamine use;
2. 2.treatment retention;

Conditions

Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse

Keywords

methamphetamine; crystal meth; addiction; los angeles; medication; meth

Outcome Measures

Primary Outcomes (1)

• Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo.

  Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 24 urine drug screens to provide during the 8 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.

  8-weeks

Secondary Outcomes (1)

• Retention (Completion)

  8-weeks

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

Varenicline: 0.5 mg daily for days 1-3 0.5 mg twice daily for days 4-7 1 mg twice daily from day 8 until end of week 8.

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

8 weeks of daily matching oral placebo in tablet form

Drug: Placebo

Interventions

Varenicline DRUG

Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).

Also known as: CHANTIX (tm)

Varenicline

Placebo DRUG

Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• meet (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria for methamphetamine (MA) dependence;
• seeking treatment for MA problems;
• willing and able to comply with study procedures;
• willing and able to provide written informed consent;
• if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial.

You may not qualify if:

• have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active tuberculosis, unstable cardiac, renal, or liver disease, uncontrolled hypertension, unstable diabetes);
• have a current neurological disorder (e.g., organic brain disease, dementia) or a medical history which would make study agent compliance difficult or which would compromise informed consent;
• have a current major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the Structured Clinical Interview for DSM Disorders (SCID);
• have a history of attempted suicide in the past 3 years and/or serious suicidal intention or plan in the past year as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS);
• currently on prescription medication that is contraindicated for use with varenicline;
• currently using any form of nicotine replacement therapy, due to potential interactions with varenicline;
• have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV;
• have a history of alcohol dependence within the past three years;
• have a history of sensitivity to varenicline or any other circumstances that, in the opinion of the investigators, would compromise participant safety.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UCLA Vine Street Clinic

Los Angeles, California, 90038, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Interventions

Varenicline; Sugars

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Carbohydrates

Limitations and Caveats

Limitations in funding resulted in a small number of subjects enrolled.

Results Point of Contact

• Title: Steve Shoptaw PhD
• Organization: University of California, Los Angeles

sshoptaw@mednet.ucla.edu

310 794 0619

Study Officials

• Steven Shoptaw, PhD

  UCLA Dept of Family Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 14, 2013
• Results First Posted: March 14, 2013

Record last verified: 2013-02

Locations

US (1)