Varenicline for Methamphetamine Dependence

NCT01365819 | Completed Phase 2 Results DMC

• 1 other identifier: Shoptaw_varen2011
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse

Keywords

Crystal meth dependence; crystal meth; methamphetamine dependence; substance abuse

Outcome Measures

Primary Outcomes (1)

• End of Treatment Abstinence

  The primary analysis will compare two weeks continuous MA abstinence at end of treatment during weeks 8 and 9 among participants randomly assigned to receive varenicline versus those randomly assigned to receive placebo.

  9 weeks

Secondary Outcomes (1)

• Number of Days Retained in Trial

  9 weeks

Other Outcomes (3)

• Prevalence of Relapse Following Initiation of Abstinence During Treatment

  7 weeks

• Reduced MA Withdrawal Symptoms

  9 weeks

• Reduction in Cigarette Smoking

  9 weeks

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Varenicline

EXPERIMENTAL

Varenicline (Chantix (R))

Drug: Varenicline

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 9).

Also known as: Chantix

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 9).

Also known as: Sugar pill

Sugar pill

Eligibility Criteria

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

You may qualify if:

• Contact site for additional information.

You may not qualify if:

• Contact site for additional information.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Vine Street Clinic

Los Angeles, California, 90036, United States

Location

Related Publications (2)

• Zorick T, Sevak RJ, Miotto K, Shoptaw S, Swanson AN, Clement C, De La Garza R 2nd, Newton TF, London ED. Pilot safety evaluation of varenicline for the treatment of methamphetamine dependence. J Exp Pharmacol. 2009 Dec 24;2:13-8. eCollection 2010.

  PMID: 27186086 BACKGROUND

• Briones M, Shoptaw S, Cook R, Worley M, Swanson AN, Moody DE, Fang WB, Tsuang J, Furst B, Heinzerling K. Varenicline treatment for methamphetamine dependence: A randomized, double-blind phase II clinical trial. Drug Alcohol Depend. 2018 Aug 1;189:30-36. doi: 10.1016/j.drugalcdep.2018.04.023. Epub 2018 May 25.

  PMID: 29860057 RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Varenicline; Sugars

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Steve Shoptaw
• Organization: UCLA, Dept of Family Medicine

sshoptaw@mednet.ucla.edu

310-794-0619

Study Officials

• Steven Shoptaw, PhD

  UCLA DGSOM Dept Of Family Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 3, 2011
• Study Start: February 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 18, 2018
• Results First Posted: February 24, 2017

Record last verified: 2018-01

Locations

US (1)