Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04604509
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bupropion Hydrochloride Controlled-release — DRUG
    Given PO
  • Nicotine Replacement — DRUG
    Given via nicotine patch, lozenges, or gum
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Tobacco Cessation Counseling — OTHER
    Receive behavioral smoking cessation counseling
  • Varenicline — DRUG
    Given PO

Study Details

This phase IV trial investigates how to personalize treatments (such as medications and/or counseling) for quitting smoking based on the unique character traits of participants. Nicotine replacement therapy, counseling, and/or drugs such as varenicline and bupropion may help participants quit smoking or change smoking behavior. This trial may also help doctors individualize smoking cessation treatment for participants who do not quit smoking after the first course of treatment.

Key Dates

Start date
Aug 4, 2020
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
2,010 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group I (varenicline, counseling)
    Participants receive varenicline PO daily or BID for 6 weeks in the absence of unacceptable toxicity. Participants who quit smoking continue treatment for 6 additional weeks in the absence of unacceptable toxicity. Participants also receive behavioral smoking cessation counseling.
  • Experimental: Group II (NRT, counseling)
    Participants receive NRT consisting of a patch, lozenges, or gum daily for 6 weeks in the absence of unacceptable toxicity. Participants who quit smoking continue treatment for 6 additional weeks in the absence of unacceptable toxicity. Participants also receive behavioral smoking cessation counseling.
  • Experimental: Group III (varenicline or NRT, counseling)
    Participants continue to receive varenicline as in Group I or NRT as in Group II for 6 additional weeks depending on which group they were assigned to. Participants also receive behavioral smoking cessation counseling.
  • Experimental: Group IV (varenicline or NRT, counseling)
    Participants switch to a different therapy and receive varenicline as in Group I or NRT as in Group II for 6 weeks depending on which group they were assigned to. Participants also receive behavioral smoking cessation counseling.
  • Experimental: Group V (higher dose varenicline or NRT, counseling)
    Participants receive a higher dose and continue to receive varenicline as in Group I or NRT as in Group II for 6 weeks depending on which group they were assigned to. Participants also receive behavioral smoking cessation counseling.
  • Experimental: Group VI (varenicline or NRT, bupropion, counseling)
    Participants continue to receive varenicline as in Group I or NRT as in Group II for 6 weeks depending on which group they were assigned to. Participants also receive bupropion PO daily for 6 weeks and behavioral smoking cessation counseling.
  • Experimental: Group VII (varenicline and NRT, counseling)
    Participants receive varenicline as in Group I and NRT as in Group II for 6 weeks. Participants also receive behavioral smoking cessation counseling.

Primary Outcome Measure

End of treatment seven-day point prevalence [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Jason Robinson
[email protected]
713-745-3822
Jason Robinson (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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