Minocycline and Tobacco Craving in Smokers With Schizophrenia

NCT02968602 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: HP-000721104K23DA034034-04
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Craving for cigarettes is an important aspect that leads to challenges with smoking cessation. Persons with schizophrenia are more likely to smoke and to be heavier smokers than persons without schizophrenia, and may experience craving differently as well. Minocycline is an antibiotic medication that may impact craving. We will conduct a two-week randomized, double-blind, placebo-controlled, parallel group pilot study to investigate the effects of minocycline vs. placebo on craving and smoking behaviors in smokers with schizophrenia. Participants will take minocycline or matching placebo for two weeks. Participants will be assessed on aspects of craving and smoking behavior at baseline and after 1 and 2 weeks of minocycline or placebo treatment.

Conditions

Schizophrenia; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Questionnaire for Smoking Urges-Brief

  This is a 10-item assessment used to measure craving to smoke and used in studies of smokers with schizophrenia. This scale has a score range from 0-100The change in QSU-Brief craving scores between time points (baseline to week 1, and baseline to week 2) will be assessed. The change in scores between the two timepoints will be calculated. The higher the score the stronger the urge to smoke is.

  Baseline, Week 1, and Week 2

Study Arms (2)

Minocycline

EXPERIMENTAL

Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.

Drug: Minocycline

Placebo

PLACEBO COMPARATOR

Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.

Other: Placebo

Interventions

Minocycline DRUG

Minocycline capsules taken twice daily for two weeks.

Minocycline

Placebo OTHER

Placebo capsules taken twice daily for two weeks.

Placebo

Eligibility Criteria

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

You may qualify if:

• DSM-IV or DSM-5 diagnosis of schizophrenia or schizoaffective disorder
• Male or Female
• Age: 18 to 65 years
• Caucasian or Non-Caucasian
• Smoke at least 10 cigarettes daily
• Urine cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
• Agrees to wear a head mounted display (HMD) for up to 45 minutes
• Able to complete the Evaluation to Sign Consent (ESC) with minimum score of 80%

You may not qualify if:

• History of organic brain disease
• DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except nicotine)
• DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except nicotine)
• Pregnancy or lactation
• Severe liver dysfunction (LFT 3X upper limit of normal)
• Previous known hypersensitivity to tetracyclines
• Current treatment with tetracycline or derivative
• Treatment with oral contraceptives (unless a second form of birth control is used and documented)
• Treatment with cholestyramine or colestipol
• Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate)
• Treatment with warfarin
• Less than two months treatment of adjunctive medications AND less than one month on same dose: beta blockers, antidepressants, mood stabilizers, antianxiety medications.
• Medical condition whose pathology or treatment would significantly increase the risk associated with the proposed protocol.
• History of head injury, seizures, or stroke
• Positive urine toxicology screen for substances of non-therapeutic use prior to craving assessments

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Maryland Psyciatric Research Center

Catonsville, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Schizophrenia; Tobacco Use

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Heidi J Wehring
• Organization: Maryland Psychiatric Research Center

hwehring@som.umaryland.edu

410-402-6854

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Treatment Research Program

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 18, 2016
• Study Start: March 31, 2017
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: January 6, 2022
• Results First Posted: October 21, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)